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The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 105 - 112
1 Jan 2021
Lynch JT Perriman DM Scarvell JM Pickering MR Galvin CR Neeman T Smith PN

Aims. Modern total knee arthroplasty (TKA) prostheses are designed to restore near normal kinematics including high flexion. Kneeling is a high flexion, kinematically demanding activity after TKA. The debate about design choice has not yet been informed by six-degrees-of-freedom in vivo kinematics. This prospective randomized clinical trial compared kneeling kinematics in three TKA designs. Methods. In total, 68 patients were randomized to either a posterior stabilized (PS-FB), cruciate-retaining (CR-FB), or rotating platform (CR-RP) design. Of these patients, 64 completed a minimum one year follow-up. Patients completed full-flexion kneeling while being imaged using single-plane fluoroscopy. Kinematics were calculated by registering the 3D implant models onto 2D-dynamic fluoroscopic images and exported for analysis. Results. CR-FB designs had significantly lower maximal flexion (mean 116° (SD 2.1°)) compared to CR-RP (123° (SD 1.6°)) and PS-FB (125° (SD 2.1°)). The PS-FB design displayed a more posteriorly positioned femur throughout flexion. Furthermore, the CR-RP femur was more externally rotated throughout kneeling. Finally, individual patient kinematics showed high degrees of variability within all designs. Conclusion. The increased maximal flexion found in the PS-FB and CR-RP designs were likely achieved in different ways. The PS-FB design uses a cam-post to hold the femur more posteriorly preventing posterior impingement. The external rotation within the CR-RP design was surprising and hasn’t previously been reported. It is likely due to the polyethylene bearing being decoupled from flexion. The findings of this study provide insights into the function of different knee arthroplasty designs in the context during deep kneeling and provide clinicians with a more kinematically informed choice for implant selection and may allow improved management of patients' functional expectations. Cite this article: Bone Joint J 2021;103-B(1):105–112


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1045 - 1051
1 Oct 2023
Turgeon TR Righolt CH Burnell CD Gascoyne TC Hedden DR Bohm ER

Aims

The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components.

Methods

Patients were randomized to receive one of the two femoral components (Avenir or Corail) during their primary total hip arthroplasty between August 2018 and September 2020. Radiostereometric analysis examinations at six, 12, and 24 months were used to assess the migration of each implanted femoral component compared to a baseline assessment. Patient-reported outcome measures were also recorded for these same timepoints. Overall, 50 patients were enrolled (62% male (n = 31), with a mean age of 65.7 years (SD 7.3), and mean BMI of 30.2 kg/m2 (SD 5.2)).


The Bone & Joint Journal
Vol. 102-B, Issue 3 | Pages 310 - 318
1 Mar 2020
Joseph MN Achten J Parsons NR Costa ML

Aims. A pragmatic, single-centre, double-blind randomized clinical trial was conducted in a NHS teaching hospital to evaluate whether there is a difference in functional knee scores, quality-of-life outcome assessments, and complications at one-year after intervention between total knee arthroplasty (TKA) and patellofemoral arthroplasty (PFA) in patients with severe isolated patellofemoral arthritis. Methods. This parallel, two-arm, superiority trial was powered at 80%, and involved 64 patients with severe isolated patellofemoral arthritis. The primary outcome measure was the functional section of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months. Secondary outcomes were the full 24-item WOMAC, Oxford Knee Score (OKS), American Knee Society Score (AKSS), EuroQol five dimension (EQ-5D) quality-of-life score, the University of California, Los Angeles (UCLA) Physical Activity Rating Scale, and complication rates collected at three, six, and 12 months. For longer-term follow-up, OKS, EQ-5D, and self-reported satisfaction score were collected at 24 and 60 months. Results. Among 64 patients who were randomized, five patients did not receive the allocated intervention, three withdrew, and one declined the intervention. There were no statistically significant differences in the patients’ WOMAC function score at 12 months (adjusted mean difference, -1.2 (95% confidence interval -9.19 to 6.80); p = 0.765). There were no clinically significant differences in the secondary outcomes. Complication rates were comparable (superficial surgical site infections, four in the PFA group versus five in the TKA group). There were no statistically significant differences in the patients’ OKS score at 24 and 60 months or self-reported satisfaction score or pain-free years. Conclusion. Among patients with severe isolated patellofemoral arthritis, this study found similar functional outcome at 12 months and mid-term in the use of PFA compared with TKA. Cite this article: Bone Joint J 2020;102-B(3):310–318


Bone & Joint Open
Vol. 4, Issue 3 | Pages 205 - 209
16 Mar 2023
Jump CM Mati W Maley A Taylor R Gratrix K Blundell C Lane S Solanki N Khan M Choudhry M Shetty V Malik RA Charalambous CP

Aims. Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB. Methods. The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after GHJ injection or SSNB in patients with frozen shoulder. This will help provide effective treatment to patients with frozen shoulder. Cite this article: Bone Jt Open 2023;4(3):205–209


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 10 - 16
1 Jul 2019
Fillingham YA Darrith B Calkins TE Abdel MP Malkani AL Schwarzkopf R Padgett DE Culvern C Sershon RA Bini S Della Valle CJ

Aims. Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. Patients and Methods. From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence. Results. In total, one patient withdrew, five did not undergo surgery, 16 were screening failures, and 25 did not receive the assigned treatment, leaving 186 patients for analysis. There was no significant difference in haemoglobin reduction among treatments (2.8 g/dl for single-dose IV TXA, 2.6 g/dl for double-dose IV TXA, 2.6 g/dl for combined IV/topical TXA, 2.9 g/dl for oral TXA; p = 0.38). Similarly, calculated blood loss (p = 0.65) and transfusion rates (p = 0.95) were not significantly different between groups. Equivalence testing assuming a 1 g/dl difference in haemoglobin change as clinically relevant showed that all possible pairings were statistically equivalent. Conclusion. Despite the higher risk of blood loss in revision TKA, all TXA regimens tested had equivalent blood-sparing properties. Surgeons should consider using the lowest effective dose and least costly TXA regimen in revision TKA. Cite this article: Bone Joint J 2019;101-B(Supple 7):10–16


The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1498 - 1505
1 Dec 2019
Sonntag J Woythal L Rasmussen P Branner U Hølmer P Jensen AK Lange KHW Brorson S

Aims. The aim of this study was to investigate the difference in functional outcome after repair and non-repair of the pronator quadratus muscle in patients undergoing surgical treatment for a distal radial fracture with volar plating. Patients and Methods. A total of 72 patients with a distal radial fracture were included in this randomized clinical trial. They were allocated to have the pronator quadratus muscle repaired or not, after volar locked plating of a distal radial fracture. The patients, the assessor, the primary investigator, and the statistician were blinded to the allocation. Randomization was irreversibly performed using a web application that guaranteed a secure and tamper-free assignment. The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) after 12 months. Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH) score, pronation strength, grip strength, the range of pronation and supination, complications, and the operating time. Results. Of the 72 patients, 63 (87.5%) completed follow-up for the primary outcome measure: 31 (86.1%) from the non-repair group and 32 (88.9%) from the repair group. At the 12-month follow-up, the mean difference in PRWE of 5.47 (95% confidence interval (CI) -4.02 to 14.96) between the repair (mean 18.38 (95% CI 10.34 to 26.41)) and non-repair group (mean 12.90 (95% CI 7.55 to 18.25)) was not statistically significant (p = 0.253). There was a statistically significant difference between pronation strength, favouring non-repair. We found no difference in the other secondary outcomes. Conclusion. We found that repairing pronator quadratus made no difference to the clinical outcome, 12 months after volar plating of a distal radial fracture. We conclude that there is no functional advantage in repairing this muscle under these circumstances and advise against it. Cite this article: Bone Joint J 2019;101-B:1498–1505


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims. Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. Methods. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group. Conclusion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78


The Bone & Joint Journal
Vol. 104-B, Issue 12 | Pages 1343 - 1351
1 Dec 2022
Karlsson T Försth P Skorpil M Pazarlis K Öhagen P Michaëlsson K Sandén B

Aims

The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion.

Methods

The Swedish Spinal Stenosis Study (SSSS) was conducted between 2006 and 2012 at five public and two private hospitals. Six centres participated in this two-year MRI follow-up. We randomized 222 patients with central lumbar spinal stenosis at one or two adjacent levels into two groups, decompression alone and decompression with fusion. The presence or absence of a preoperative spondylolisthesis was noted. A new stenosis on two-year MRI was used as the primary outcome, defined as a dural sac cross-sectional area ≤ 75 mm2 at the operated level (restenosis) and/or at the level above (proximal adjacent level stenosis).


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1385 - 1391
1 Oct 2018
Qvist AH Væsel MT Jensen CM Jensen SL

Aims

Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.

Patients and Methods

In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 33 - 41
1 Jan 2020
Norman JG Brealey S Keding A Torgerson D Rangan A

Aims

The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures

Methods

A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 279 - 285
1 Feb 2021
Ferguson D Harwood P Allgar V Roy A Foster P Taylor M Moulder E Sharma H

Aims

Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

Methods

Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system.


Aims

Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures.

Methods

We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 762 - 768
1 Apr 2021
Ban I Kristensen MT Barfod KW Eschen J Kallemose T Troelsen A

Aims

To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups.

Methods

Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes.


Bone & Joint 360
Vol. 11, Issue 6 | Pages 37 - 40
1 Dec 2022

The December 2022 Trauma Roundup. 360. looks at: Anterior approach for acetabular fractures using anatomical plates; Masquelet–Ilizarov for the management of bone loss post debridement of infected tibial nonunion; Total hip arthroplasty – better results after low-energy displaced femoral neck fracture in young patients; Unreamed intramedullary nailing versus external fixation for the treatment of open tibial shaft fractures in Uganda: a randomized clinical trial; The Open-Fracture Patient Evaluation Nationwide (OPEN) study: the management of open fracture care in the UK; Cost-utility analysis of cemented hemiarthroplasty versus hydroxyapatite-coated uncemented hemiarthroplasty; Unstable ankle fractures: fibular nail fixation compared to open reduction and internal fixation; Long-term outcomes of randomized clinical trials: wrist and calcaneus; ‘HeFT’y follow-up of the UK Heel Fracture Trial


Bone & Joint 360
Vol. 12, Issue 5 | Pages 36 - 39
1 Oct 2023

The October 2023 Trauma Roundup. 360. looks at: Intramedullary nailing versus sliding hip screw in trochanteric fracture management: the INSITE randomized clinical trial; Five-year outcomes for patients with a displaced fracture of the distal tibia; Direct anterior versus anterolateral approach in hip joint hemiarthroplasty; Proximal humerus fractures: treat them all nonoperatively?; Tranexamic acid administration by prehospital personnel; Locked plating versus nailing for proximal tibia fractures: a multicentre randomized controlled trial; A retrospective review of the rate of septic knee arthritis after retrograde femoral nailing for traumatic femoral fractures at a single academic institution


Bone & Joint 360
Vol. 13, Issue 3 | Pages 37 - 40
3 Jun 2024

The June 2024 Trauma Roundup. 360. looks at: Skin antisepsis before surgical fixation of limb fractures; Comparative analysis of intramedullary nail versus plate fixation for fibula fracture in supination external rotation type IV ankle injury; Early weightbearing versus late weightbearing after intramedullary nailing for distal femoral fracture (AO/OTA 33) in elderly patients: a multicentre propensity-matched study; Long-term outcomes with spinal versus general anaesthesia for hip fracture surgery; Operative versus nonoperative management of unstable medial malleolus fractures: a randomized clinical trial; Impact of smoking status on fracture-related infection characteristics and outcomes; Reassessing empirical antimicrobial choices in fracture-related infections; Development and validation of the Nottingham Trauma Frailty Index (NTFI) for older trauma patients


Bone & Joint 360
Vol. 12, Issue 1 | Pages 36 - 39
1 Feb 2023

The February 2023 Trauma Roundup. 360. looks at: Masquelet versus bone transport in infected nonunion of tibia; Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multicentre randomized clinical trial; Is the T-shaped acetabular fracture really a “T”?; What causes cut-out of proximal femur nail anti-rotation device in intertrochanteric fractures?; Is the common femoral artery at risk with percutaneous fragility pelvis fixation?; Anterior pelvic ring pattern predicts displacement in lateral compression fractures; Differences in age-related characteristics among elderly patients with hip fractures


Bone & Joint 360
Vol. 12, Issue 6 | Pages 31 - 34
1 Dec 2023

The December 2023 Shoulder & Elbow Roundup. 360. looks at: Clavicle fractures: is the evidence changing practice?; Humeral shaft fractures, and another meta-analysis…let’s wait for the trials now!; Hemiarthroplasty or total elbow arthroplasty for distal humeral fractures…what does the registry say?; What to do with a first-time shoulder dislocation?; Deprivation indices and minimal clinically important difference for patient-reported outcomes after arthroscopic rotator cuff repair; Prospective randomized clinical trial of arthroscopic repair versus debridement for partial subscapularis tears; Long-term follow-up following closed reduction and early movement for simple dislocation of the elbow; Sternoclavicular joint reconstruction for traumatic acute and chronic anterior and posterior instability


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


Bone & Joint Open
Vol. 1, Issue 2 | Pages 3 - 7
5 Feb 2020
Widnall J Capstick T Wijesekera M Messahel S Perry DC

Aims. This study sought to estimate the clinical outcomes and describe the nationwide variation in practice, as part of the feasibility workup for a National Institute for Health and Care Excellence (NICE) recommended randomized clinical trial to determine the optimal treatment of torus fractures of the distal radius in children. Methods. Prospective data collection on torus fractures presenting to our emergency department. Patient consent and study information, including a copy of the Wong-Baker Faces pain score, was issued at the first patient contact. An automated text message service recorded pain scores at days 0, 3, 7, 21, and 42 postinjury. A cross-sectional survey of current accident and emergency practice in the UK was also undertaken to gauge current practice following the publication of NICE guidance. Results. In all, 30 patients with a mean age of 8.9 years were enrolled over a six-week period. Of the 150 potential data points, data was captured in 146, making the data 97.3% complete. Pain scores were recorded at day 0 (mean 6.5 (95% confidence interval (CI) 5.7 to 7.3)), day 3 (4.4 (95% CI 3.5 to 5.2)), day 7 (3.0 (95% CI 2.3 to 3.6)), day 21 (1.2 (95% CI 0.7 to 1.7)) and day 42 (0.4 (95% CI 0.1 to 0.7)). Of the 100 units who participated in the nationwide survey, 38% were unaware of any local or national protocols regarding torus fractures, 41% treated torus fractures with cast immobilization, and over 60% of patients had follow-up arranged, both contradictory to national guidelines. Conclusion. We have demonstrated the severity, recovery trajectory, and variation in pain scores among children with torus fractures. We demonstrate excellent follow-up of patient outcomes using text messages. Despite national guidelines, there is significant variation in practice. This data directly informed the development of an ongoing nationwide randomized clinical trial – the FORearm Fracture Recovery in Children Evaluation (FORCE) study


Bone & Joint 360
Vol. 12, Issue 1 | Pages 30 - 33
1 Feb 2023

The February 2023 Shoulder & Elbow Roundup. 360. looks at: Arthroscopic capsular release or manipulation under anaesthesia for frozen shoulder?; Distal biceps repair through a single incision?; Distal biceps tendon ruptures: diagnostic strategy through physical examination; Postoperative multimodal opioid-sparing protocol vs standard opioid prescribing after knee or shoulder arthroscopy: a randomized clinical trial; Graft healing is more important than graft technique in massive rotator cuff tear; Subscapularis tenotomy versus peel after anatomic shoulder arthroplasty; Previous rotator cuff repair increases the risk of revision surgery for periprosthetic joint infection after reverse shoulder arthroplasty; Conservative versus operative treatment of acromial and scapular spine fractures following reverse total shoulder arthroplasty


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 88 - 88
10 Feb 2023
Seth I Bulloch G Seth N Fogg Q Hunter-Smith D Rozen W
Full Access

The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values < 0.05 were considered statistically significant. A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%). Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 656 - 661
1 Jul 2024
Bolbocean C Hattab Z O'Neill S Costa ML

Aims. Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. Methods. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively. Results. Our analysis revealed a complex landscape of responses to the use of a cemented hemiarthroplasty in the 12 months after surgery. There was heterogeneity of effects with regard to baseline characteristics, including age, pre-injury health status, and lifestyle factors such as alcohol consumption. This heterogeneity was greater at the one-month mark than at subsequent follow-up timepoints, with particular regard to subgroups based on age. However, for all subgroups, the effect estimates for quality of life lay within the confidence intervals derived from the analysis of all patients. Conclusion. The use of a cemented hemiarthroplasty is expected to increase health-related quality of life compared with modern uncemented hemiarthroplasty for all subgroups of patients aged > 60 years with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2024;106-B(7):656–661


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 11 - 11
8 May 2024
Daniels T
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Introduction/Purpose. A randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years. Methods. One hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated. Results. Of 119 patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4–8.0), 9 underwent implant removal and conversion to fusion in years 2–5, leaving 106 patients. The implant survival rate was 92.4% at 5.8 years. Pain and function outcomes at 5.8 years were similar to those at 2 years. VAS Pain, FAAM Sports, ADL Scores were maintained or improved at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed. There were no unanticipated safety events through 5.8 years. Ninety-three (93%) percent would have the procedure again. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with evidence of therapeutic effect and acceptable safety profile at 5.8 years


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). Methods. An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. Results. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion. This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK. Cite this article: Bone Jt Open 2024;5(7):612–620


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 86 - 86
24 Nov 2023
Veerman K Telgt D Rijnen W Goosen J
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Aim. In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty. Method. This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up. Results. After randomization of 662 patients, 68 unexpected PJI were diagnosed. In 5 cases no antimicrobial treatment was started. The success rate after one year follow-up for those who received PJI treatment was 96% (28/29) in the single dose group and 91% (31/34) in the extended prophylaxis group (p=1.00). The most frequently identified pathogens in unexpected PJI were Cutibacterium acnes (n=50) and Staphylococcus epidermidis (n=14). The causatives were susceptible for the cefazolin prophylaxis in 61 of the 63 cases. The interval between the stopped prophylaxis and the re-start of antimicrobial treatment was on average 10 days (SD 4) for the single dose and 5 days (SD 4) for the extended group. The mean duration of antimicrobial treatment was 83 days (SD 12) and did not differ between both groups (p=0.16). Conclusions. This is the first randomized controlled trial in which extended prophylaxis showed no benefit on the prosthesis survival for patients with an unexpected PJI after assumed aseptic revision of the hip or knee prosthesis. The results imply that extended prophylaxis should not be given as part of early empiric therapy


Bone & Joint Open
Vol. 3, Issue 7 | Pages 529 - 535
1 Jul 2022
Wormald JCR Rodrigues JN Cook JA Prieto-Alhambra D Costa ML

Aims. Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial. Methods. A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work. Conclusion. This will inform a definitive trial of antimicrobial sutures in the hand and wrist, and will help to inform future upper limb trauma trials. The results of this research will be shared with the medical community through high impact publication and presentation. Cite this article: Bone Jt Open 2022;3(7):529–535


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 32 - 32
1 Dec 2022
Kamikovski I Woodmass J McRae S Lapner P Jong B Marsh J Old J Dubberley J Stranges G MacDonald PB
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Previously, we conducted a multi-center, double-blinded randomized controlled trial comparing arthroscopic Bankart repair with and without remplissage. The end point for the randomized controlled trial was two years post-operative, providing support for the benefits of remplissage in the short term in reducing recurrent instability. The aim of this study was to compare the medium term (3 to 9 years) outcomes of patients previously randomized to have undergone isolated Bankart repair (NO REMP) or Bankart repair with remplissage (REMP) for the management of recurrent anterior glenohumeral instability. The rate of recurrent instability and instances of re-operation were examined. The original study was a double-blinded, randomized clinical trial with two 1:1 parallel groups with recruitment undertaken between 2011 and 2017. For this medium-term study, participants were reached for a telephone follow-up in 2020 and asked a series of standardized questions regarding ensuing instances of subluxation, dislocation or reoperation that had occurred on their shoulder for which they were randomized. Descriptive statistics were generated for all variables. “Failure” was defined as occurrence of a dislocation. “Recurrent instability” was defined as the participant reporting a dislocation or two or more occurences of subluxation greater than one year post-operative. All analyses were undertaken based on intention-to-treat whereby their data was analyzed based on the group to which they were originally allocated. One-hundred and eight participants were randomized of which 50 in the NO REMP group and 52 in the REMP group were included in the analyses in the original study. The mean number of months from surgery to final follow-up was 49.3 for the NO REMP group and 53.8 for the REMP group. The rates of re-dislocation or failure were 8% (4/52) in the REMP group at an average of 23.8 months post-operative versus 22% (11/50) in the NO REMP at an average of 16.5 months post-operative. The rates of recurrent instability were 10% (5/52) in the REMP group at an average of 24 months post-operative versus 30% (15/50) in the NO REMP group at an average of 19.5 months post-operative. Survival curves were significantly different favouring REMP in both scenarios. Arthroscopic Bankart repair combined with remplissage is an effective procedure in the treatment of patients with an engaging Hill-Sachs lesion and minimal glenoid bone loss (<15%). Patients can expect favourable rates of recurrent instability when compared with isolated Bankart repair at medium term follw-up


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 17 - 17
1 Dec 2022
Ciapetti G Granchi D Perut F Spinnato P Spazzoli B Cevolani L Donati DM Baldini N
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Fracture nonunion is a severe clinical problem for the patient, as well as for the clinician. About 5-20% of fractures does not heal properly after more than six months, with a 19% nonunion rate for tibia, 12% for femur and 13% for humerus, leading to patient morbidity, prolonged hospitalization, and high costs. The standard treatment with iliac crest-derived autologous bone filling the nonunion site may cause pain or hematoma to the patient, as well as major complications such as infection. The application of mesenchymal autologous cells (MSC) to improve bone formation calls for randomized, open, two-arm clinical studies to verify safety and efficacy. The ORTHOUNION * project (ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs) is a multicentric, open, randomized, comparative phase II clinical trial, approved in the framework of the H2020 funding programme, under the coordination of Enrique Gòmez Barrena of the Hospital La Paz (Madrid, Spain). Starting from January 2017, patients with nonunion of femur, tibia or humerus have been actively enrolled in Spain, France, Germany, and Italy. The study protocol encompasses two experimental arms, i.e., autologous bone marrow-derived mesenchymal cells after expansion (‘high dose’ or ‘low dose’ MSC) combined to ceramic granules (MBCP™, Biomatlante), and iliac crest-derived autologous trabecular bone (ICAG) as active comparator arm, with a 2-year follow-up after surgery. Despite the COVID 19 pandemic with several lockdown periods in the four countries, the trial was continued, leading to 42 patients treated out of 51 included, with 11 receiving the bone graft (G1 arm), 15 the ‘high dose’ MSC (200x10. 6. , G2a arm) and 16 the ‘low dose’ MSC (100x10. 6. , G2b arm). The Rizzoli Orthopaedic Institute has functioned as coordinator of the Italian clinical centres (Bologna, Milano, Brescia) and the Biomedical Science and Technologies and Nanobiotechnology Lab of the RIT Dept. has enrolled six patients with the collaboration of the Rizzoli’ 3rd Orthopaedic and Traumatological Clinic prevalently Oncologic. Moreover, the IOR Lab has collected and analysed the blood samples from all the patients treated to monitor the changes of the bone turnover markers following the surgical treatment with G1, G2a or G2b protocols. The clinical and biochemical results of the study, still under evaluation, are presented. * ORTHOUNION Horizon 2020 GA 733288


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 18 - 18
24 Nov 2023
De Meo D Martini P Pennarola M Candela V Torto FL Ceccarelli G Gumina S Villani C
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Aim. There are no studies in literature that analyze the effectiveness of closed-incisional negative pressure wound therapy (ciNPWT) in the treatment of bone and joint infections (BJI). The aim of the study was to evaluate the efficacy and the safety of the application of ciNPWT in the postsurgical wound management of patients with osteoarticular infections. Method. We conducted a perspective single-center study on patients with BJI treated between 01/2022 and 10/2022 with ciNPWT dressing application at the end of the surgical procedure. All patients were treated by a multidisciplinary team (MDT) approach and operated by the same surgical equipe. Inclusion criteria were: presence of periprosthetic joint infection (PJI), fracture-related infection (FRI), osteomyelitis (OM), septic arthritis (SA) surgically treated, after which ciNPTW was applied over the closed surgical wound. 30 patients (19M, 11F) have been analyzed with mean age of 56,10±17,11 years old; BJIs were all localized in the lower limb (16 PJI, 12 FRI, 1 SA, 1 OM). Results. We considered the following clinical local pre-operative parameters: presence of fistula (10 patients, 33,33%), presence of erythema (18 patients, 60%), presence of previous flap in the incisional site (7 patients, 23,33%). In 11 cases (36,67%) more than 3 previous surgical procedures were performed in the surgical site. The following surgical procedures were performed: 8 debridement and implants removal, 7 DAIR, 3 one-stage exchange, 6 two-stage exchange, 3 spacer exchange, 3 resection arthroplasty. Nineteen patients (63,34%) showed no occurrence of any local post-operative complication (erythema, hematoma, wound breakdown, wound blister, necrosis). Seven (23,33%) patients showed the presence of one or more postoperative complications that didn't require additional surgery. We observed four (13,33%) failures, defined as the need for further surgical procedures following the onset of a local complication: two patients had a wound breakdown before wound closure and two had a recurrence of infection after an uneventfully wound closure. All failures were within the group of joint infection (PJI+SA) and were affected by a multi drug resistant pathogen. Conclusions. In our series four patients required further surgery, but only two cases were related to incisional wound problems, that is consistent with aseptic joint revision surgeries data that are available in literature (3.4%-6.9%)[1-2]. Patients affected by BJI are a group with significant high risk of failure and therefore the use of ciNPWT should be considered. However, randomized clinical trials are needed to establish the superiority of the ciNPWT dressing over the standard one


Bone & Joint Open
Vol. 3, Issue 4 | Pages 321 - 331
8 Apr 2022
Dean BJF Srikesavan C Horton R Toye F

Aims. Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results. A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to ‘no treatment’ ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. Conclusion. Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321–331


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 510 - 518
1 Apr 2022
Perry DC Arch B Appelbe D Francis P Craven J Monsell FP Williamson P Knight M

Aims. The aim of this study was to evaluate the epidemiology and treatment of Perthes’ disease of the hip. Methods. This was an anonymized comprehensive cohort study of Perthes’ disease, with a nested consented cohort. A total of 143 of 144 hospitals treating children’s hip disease in the UK participated over an 18-month period. Cases were cross-checked using a secondary independent reporting network of trainee surgeons to minimize those missing. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. Overall, 371 children (396 hips) were newly affected by Perthes’ disease arising from 63 hospitals, with a median of two patients (interquartile range 1.0 to 5.5) per hospital. The annual incidence was 2.48 patients (95% confidence interval (CI) 2.20 to 2.76) per 100,000 zero- to 14-year-olds. Of these, 117 hips (36.4%) were treated surgically. There was considerable variation in the treatment strategy, and an optimized decision tree identified joint stiffness and age above eight years as the key determinants for containment surgery. A total of 348 hips (88.5%) had outcomes to two years, of which 227 were in the late reossification stage for which a hip shape outcome (Stulberg grade) was assigned. The independent predictors of a poorer radiological outcome were female sex (odds ratio (OR) 2.27 (95% CI 1.19 to 4.35)), age above six years (OR 2.62 (95% CI (1.30 to 5.28)), and over 50% radiological collapse at inclusion (OR 2.19 (95% CI 0.99 to 4.83)). Surgery had no effect on radiological outcomes (OR 1.03 (95% CI 0.55 to 1.96)). PROMs indicated the marked effect of the disease on the child, which persisted at two years. Conclusion. Despite the frequency of containment surgery, we found no evidence of improved outcomes. There appears to be a sufficient case volume and community equipoise among surgeons to embark on a randomized clinical trial to definitively investigate the effectiveness of containment surgery. Cite this article: Bone Joint J 2022;104-B(4):510–518


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 47 - 47
1 Nov 2021
Gindraux F
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The human amniotic membrane (hAM), derived from the placenta, possesses a low (nay inexistant) immunogenicity and exerts an anti-inflammatory, anti-fibrotic, antimicrobial, antiviral and analgesic effect. It is a source of stem cells and growth factors promoting tissue regeneration. hAM acts as an anatomical barrier with adequate mechanical properties (permeability, stability, elasticity, flexibility, resorbability) preventing the proliferation of fibrous tissue and promoting early neovascularization of the surgical site. Cryopreservation and lyophilization, with sometimes additional decellularization process, are the main preservation methods for hAM storage. We examined the use of hAM in orthopaedic and maxillofacial bone surgery, specially to shorten the induced membrane technique (Gindraux, 2017). We investigated the cell survival in cryopreserved hAM (Laurent, 2014) and the capacity of intact hAM of in vitro osteodifferentiation (Gualdi, 2019). We explored its in vivo osteogenic potential in an ectopic model (Laurent, 2017) and, with Inserm U1026 BioTis, in a calvarial defect (Fenelon, 2018). Still piloted by U1026, decellularization and/or lyophilization process were developed (Fenelon, 2019) and, processed hAM capacities was assessed for guided bone regeneration (Fenelon 2020) and induced membrane technique (Fenelon, 2021) in mice. We reported a limited function of hAM for bone defect management. In this light, we recognized medication-related osteonecrosis of the jaw (MRONJ) as appropriate model of disease to evaluate hAM impact on both oral mucosa and bone healing. We treated height compassionate patients (stage II, III) with cryopreserved hAM. A multicentric randomized clinical study (PHRC-I 2020 funding) will be soon conducted in France (regulatory and ethical authorization in progress)


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1072 - 1081
1 Aug 2020
Png ME Madan JJ Dritsaki M Achten J Parsons N Fernandez M Grant R Nanchahal J Costa ML

Aims. To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The incremental cost of standard dressing versus iNPWT over six months was £2,037 (95% confidence interval (CI) £349 to £3,724). There was an insignificant increment in QALYs gained in the iNPWT group (0.005, 95% CI -0.018 to 0.028). The probability of iNPWT being cost-effective at £20,000 per QALY was 1.9%. The results remained robust in the sensitivity analysis. Conclusion. The within-trial economic evaluation suggests that iNPWT is unlikely to be a cost-effective alternative to standard dressing in adults with closed surgical wounds to their lower limbs. Cite this article: Bone Joint J 2020;102-B(8):1072–1081


Aims. The aim is to assess the cost-effectiveness of patellofemoral arthroplasty (PFA) in comparison with total knee arthroplasty (TKA) for the treatment of isolated patellofemoral osteoarthritis (OA) based on prospectively collected data on health outcomes and resource use from a blinded, randomized, clinical trial. Methods. A total of 100 patients with isolated patellofemoral osteoarthritis were randomized to receive either PFA or TKA by experienced knee surgeons trained in using both implants. Patients completed patient-reported outcomes including EuroQol five-dimension questionnaire (EQ-5D) and 6-Item Short-Form Health Survey questionnaire (SF-6D) before the procedure. The scores were completed again after six weeks, three, six, and nine months, and again after one- and two-year post-surgery and yearly henceforth. Time-weighted outcome measures were constructed. Cost data were obtained from clinical registrations and patient-reported questionnaires. Incremental gain in health outcomes (quality-adjusted life-years (QALYs)) and incremental costs were compared for the two groups of patients. Net monetary benefit was calculated assuming a threshold value of €10,000, €35,000, and €50,000 per QALY and used to test the statistical uncertainty and central assumptions about outcomes and costs. Results. The PFA group had an incremental 12 month EQ-5D gain of 0.056 (95% confidence interval (CI) 0.01 to 0.10) and an incremental 12 month cost of minus €328 (95% CI 836 to 180). PFA therefore dominates TKA by providing better and cheaper outcomes than TKA. The net monetary benefit of PFA was €887 (95% CI 324 to 1450) with the €10,000 threshold, and it was consistently positive when different measures of outcomes and different cost assumptions were used. Conclusion. This study provides robust evidence that PFA from a one-year hospital management perspective is cheaper and provides better outcomes than TKA when applied to patients with isolated patellofemoral osteoarthritis and performed by experienced knee surgeons. Cite this article: Bone Joint J 2020;102-B(4):449–457


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_5 | Pages 2 - 2
1 Mar 2021
Higuera-Rueda C Emara A Nieves-Malloure Y Klika AK Cooper H Cross M Guild G Nam D Nett M Scuderi G Cushner F Silverman R
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Aim. This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing. Method. A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained. Results. A total of 242 patients completed the required follow-up (ciNPT: n = 124 (84.4%); SOC: n = 118 (80.3%)). Demographics, baseline comorbidities, causes of revision (prosthetic joint infection, aseptic loosening, implant-related, and periprosthetic fractures), and duration of treatment were similar in both cohorts (p > 0.05). Intention to treat analysis demonstrated lower rates of SSC with ciNPT (3.4%) compared to SOC (14.3%) (p = 0.0013) (Table 1 – not included in the proceeding). Similar outcomes were obtained with the modified intention to treat analysis (p = 0.0013). The ciNPT cohort exhibited lower readmission rates (p = 0.0208), and number of dressing changes (p = 0.0003). Conversely, differences in the 90-day incidence of SSI and measured patient-reported outcomes did not reach statistical significance (p > 0.05). Conclusions. ciNPT mitigates the risk of SSC and readmission among high-risk rTKA patients. The lower frequency of dressing changes within the ciNPT cohort may provide added value for healthcare utilization without compromising pain and function. For the table, please contact authors directly


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims. Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. Methods. This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment. Anticipated impact. The 12-month results will be presented and published internationally. This is anticipated to be the only pragmatic trial reporting outcomes comparing surgical with non-surgical treatment in unstable ankle fractures in younger adults (aged 60 years and younger), and, as such, will inform the National Institute for Health and Care Excellence (NICE) ‘non-complex fracture’ recommendations at their scheduled update in 2024. A report of long-term outcomes at five years will be produced by January 2027. Cite this article: Bone Jt Open 2024;5(3):184–201


Bone & Joint Open
Vol. 1, Issue 6 | Pages 198 - 202
6 Jun 2020
Lewis PM Waddell JP

It is unusual, if not unique, for three major research papers concerned with the management of the fractured neck of femur (FNOF) to be published in a short period of time, each describing large prospective randomized clinical trials. These studies were conducted in up to 17 countries worldwide, involving up to 80 surgical centers and include large numbers of patients (up to 2,900) with FNOF. Each article investigated common clinical dilemmas; the first paper comparing total hip arthroplasty versus hemiarthroplasty for FNOF, the second as to whether ‘fast track’ care offers improved clinical outcomes and the third, compares sliding hip with multiple cancellous hip screws. Each paper has been deemed of sufficient quality and importance to warrant publication in The Lancet or the New England Journal of Medicine. Although ‘premier’ journals, they only occationally contain orthopaedic studies and thus may not be routinely read by the busy orthopaedic/surgical clinician of any grade. It is therefore our intention with this present article to accurately summarize and combine the results of all three papers, presenting, in our opinion, the most important clinically relevant facts. Cite this article: Bone Joint Open 2020;1-6:198–202


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 147 - 147
1 Mar 2008
Harato K Bourne R Marr J Overhauser J
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Purpose: The purpose of this study was to compare the outcomes of cruciate retaining (CR) and cruciate sacrificing (CS) total knee arthroplasty (TKA) in a multi-center randomized clinical trial with greater than 5 year follow-up. Methods: One hundred and eighty five patients (189 knees) participated in a double-blinded randomized clinical trial. 96 cruciate retaining and 93 cruciate sacrificing total knee arthroplasties (Genesis II, Smith & Nephew, Memphis, TN) were performed between 1997 and 2000. All surgical procedures were performed by twelve surgeons at twelve medical centers. The average follow-up was 5.8 (5.0–7.3) years. Clinical outcomes (Knee Society Clinical Rating, WOMAC, SF-12, Radiographic Findings) were evaluated preoperatively and at the latest follow-up. Postoperative complications were also examined. Results: There were no significant differences when comparing cruciate retaining knees to cruciate sacrificing knees in patient demographics and preoperative clinical evaluation. At the latest follow-up, clinical outcomes (CR versus CS) were as follows: Knee Society Clinical Rating (163±26 versus 165±29), knee flexion (114±11& #12539;versus 118±10& #12539; p< 0.05), WOMAC (12±7 versus 8±6, p< 0.05), and SF-12 (mental: 52±9 versus 58±4, physical: 41±11 versus 42±10). Radiographic outcomes showed there were no differences in radiolucent lines or loosening, and postoperative complication rate was also not significantly different. Conclusions: In this randomized clinical trial, both posterior cruciate preserving (CR) and sacrificing (CS) total knee replacements offer excellent clinical outcomes at five or more years follow-up, with the cruciate sacrificing implant studied demonstrating small, but significant improvements in both range of motion, WOMAC, and disease specific outcomes


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 56 - 56
1 Mar 2021
Schneider P Thoren J Cushnie D Del Balso C Tieszer C Sanders D
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Flexible fixation techniques combined with anatomic (open) syndesmosis reduction have demonstrated improved functional outcomes and rates of malreduction. Suture-button devices allow physiologic motion of the syndesmosis without need for implant removal, which may lower the risk of recurrent syndesmotic diastasis. There is limited longer-term assessment of the maintenance of reduction between static and flexible syndesmotic fixation using bilateral ankle CT evaluation. This is an a priori planned subgroup analysis of a multi-centre, randomized clinical trial comparing static syndesmosis fixation (two 3.5 mm screws) with flexible fixation (single knotless Tightrope) for patients with AO- OTA 44-C injuries. Patients who completed bilateral ankle CT scans at 3- and 12-month follow-up were included. The primary outcome measure was syndesmotic malreduction based on bilateral ankle CT scans, using the uninjured, contralateral ankle as a control. Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance were calculated to measure syndesmosis reduction. Secondary outcomes included re-operation, adverse events and functional outcomes including the EQ5D, Olerud-Molander Ankle Score (OM), Foot and Ankle Disability Index (FADI), and Work Productivity Activity Impairment Questionnaire (WPAI). Paired samples t-tests were used to compare injured to control ankles (R, v 3.5.1). 42 patients (24 Group S, 18 Group T) were included. ASD for Group T was 5.22mm (95%CI 4.69–5.77) at 3 months compared to 4.26mm (95%CI 3.82–4.71; p=0.007) in controls and 5.38mm (95%CI 4.72–6.04) at 12 months compared to 4.44mm (95%CI 3.73–5.16; p=0.048) in controls. ASD for Group S was 4.63mm (95%CI 4.17– 5.10) at 3 months compared to 4.67mm (95%CI 4.24–5.10; p=0.61) in controls, but significantly increased to 5.73mm (95%CI 4.81–6.66) at 12 months compared to 4.65mm (95%CI 4.15–5.15; p=0.04) in controls. MSD results were similar; Group T had a larger MSD than control ankles at 3 months (p=0.03) and 12 months (p=0.01), while the MSD in Group S was not different at 3 months (p=0.80) but increased at 12 months (p=<0.01). 88% (21/24) of Group S had broken or removed screws by 12 months. Unplanned re-operation was 15% in Group S and 4% in Group T (p=0.02), with an overall re-operation rate of 30% in Group S. There was no significant difference between treatment groups for EQ-5D, OM, FADI or WPAI at 3- or 12-month follow-up. Tightrope fixation resulted in greater diastasis of the ASD and MSD compared to contralateral, uninjured ankles at 3- and 12-months post-fixation. Group S initially had syndesmotic reduction similar to control ankles, but between 3- and 12-months post-fixation, there was significantly increased syndesmosis diastasis compared to controls. The majority of Group S (88%) had either broken screws or scheduled screw removal, which may explain the increased tibio-fibular diastasis seen at 12-months


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 34 - 34
1 Mar 2021
MacDonald P Woodmass J McRae S Verhulst F Lapner P
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Management of the pathologic long-head biceps tendon remains controversial. Biceps tenotomy is a simple intervention but may result in visible deformity and subjective cramping. Comparatively, biceps tenodesis is technically challenging, and has increased operative times, and a more prolonged recovery. The purpose of this study was to determine the incidence of popeye deformity following biceps tenotomy versus tenodesis, identify predictors for developing a deformity, and compare subjective and objective outcomes between those that have one and those that do not. Data for this study were collected as part of a randomized clinical trial comparing tenodesis versus tenotomy in the treatment of lesions of the long head of biceps tendon. Patients 18 years of age or older with an arthroscopy confirmed biceps lesion were randomized to one of these two techniques. The primary outcome measure for this sub-study was the rate of a popeye deformity at 24-months post-operative as determined by an evaluator blinded to group allocation. Secondary outcomes were patient reported presence/absence of a popeye deformity, satisfaction with the appearance of their arm, as well as pain and cramping on a VAS. Isometric elbow flexion and supination strength were also measured. Interrater reliability (Cohen's kappa) was calculated between patient and evaluator on the presence of a deformity, and logistic regression was used to identify predictors of its occurrence. Linear regression was performed to identify if age, gender, or BMI were predictive of satisfaction in appearance if a deformity was present. Fifty-six participants were randomly assigned to each group of which 42 in the tenodesis group and 45 in the tenotomy group completed a 24-month follow-up. The incidence of popeye deformity was 9.5% (4/42) in the tenodesis group and 33% (15/45) in the tenotomy group (18 male, 1 female) with a relative risk of 3.5 (p=0.016). There was strong interrater agreement between evaluator and patient perceived deformity (kappa=0.636; p<0.001). Gender tended towards being a significant predictor of having a popeye with males having 6.6 greater odds (p=0.090). BMI also tended towards significance with lower BMI predictive of popeye deformity (OR 1.21; p=0.051). Age was not predictive (p=0.191). Mean (SD) satisfaction score regarding the appearance of their popeye deformity was 7.3 (2.6). Age was a significant predictor, with lower age associated with decreased satisfaction (F=14.951, adjusted r2=0.582, p=0.004), but there was no association with gender (p=0.083) or BMI (p=0.949). There were no differences in pain, cramping, or strength between those who had a popeye deformity and those who did not. The risk of developing a popeye deformity was 3.5 times higher after tenotomy compared to tenodesis. Male gender and lower BMI tended towards being predictive of having a deformity; however, those with a high BMI may have had popeye deformities that were not as visually apparent to an examiner as those with a lower BMI. Younger patients were significantly less satisfied with a deformity despite no difference in functional outcomes at 24 months. Thus, biceps tenodesis may be favored in younger patients with low BMI to mitigate the risk of an unsatisfactory popeye deformity


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 11 - 11
1 Mar 2021
Wong M Wiens C Kooner S Buckley R Duffy P Korley R Martin R Sanders D Edwards B Schneider P
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Nearly one quarter of ankle fractures have a recognized syndesmosis injury. An intact syndesmosis ligament complex stabilizes the distal tibio-fibular joint while allowing small, physiologic amounts of relative motion. When injured, malreduction of the syndesmosis has been found to be the most important independent factor that contributes to inferior functional outcomes. Despite this, significant variability in surgical treatment remains. This may be due to a poor understanding of normal dynamic syndesmosis motion and the resultant impact of static and dynamic fixation on post-injury syndesmosis kinematics. As the syndesmosis is a dynamic structure, conventional CT static images do not provide a complete picture of syndesmosis position, giving potentially misleading results. Dynamic CT technology has the ability to image joints in real time, as they are moved through a range-of-motion (ROM). The aim of this study was to determine if syndesmosis position changes significantly throughout ankle range of motion, thus warranting further investigation with dynamic CT. This is an a priori planned subgroup analysis of a larger multicentre randomized clinical trial, in which patients with AO-OTA 44-C injuries were randomized to either Tightrope or screw fixation. Bilateral ankle CT scans were performed at 1 year post-injury, while patients moved from maximal dorsiflexion (DF) to maximal plantar flexion (PF). In the uninjured ankles, three measurements were taken at one cm proximal to the ankle joint line in maximal DF and maximal PF: Anterior (ASD), middle (MSD), and posterior (PSD) syndesmosis distance, in order to determine normal syndesmosis position. Paired samples t-tests compared measurements taken at maximal DF and maximal PF. Twelve patients (eight male, six female) were included, with a mean age of 44 years (±13years). The mean maximal DF achieved was 1-degree (± 7-degrees), whereas the mean maximal PF was 47-degrees (± 8-degrees). The ASD in DF was 3.0mm (± 1.1mm) versus 1.9mm (± 0.8mm) in PF (p<0.01). The MSD in DF was 3.3mm (±1.1mm) versus 2.3mm (±0.9mm) in PF (p<0.01). The PSD in DF was 5.3mm (±1.5mm) versus 4.6mm (±1.9mm) in PF (p<0.01). These values are consistent with the range of normal parameters previously reported in the literature, however this is the first study to report the ankle position at which these measurements are acquired and that there is a significant change in syndesmosis measurements based on ankle position. Normal syndesmosis position changes in uninjured ankles significantly throughout range of motion. This motion may contribute to the variation in normal anatomy previously reported and controversies surrounding quantifying anatomic reduction after injury, as the ankle position is not routinely standardized, but rather static measurements are taken at patient-selected ankle positions. Dynamic CT is a promising modality to quantify normal ankle kinematics, in order to better understand normal syndesmosis motion. This information will help optimize assessment of reduction methods and potentially improve patient outcomes. Future directions include side-to-side comparison using dynamic CT analysis in healthy volunteers


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 57 - 61
1 Jul 2020
Woolson ST

Aims. To establish whether there was a consensus among the members of the Hip Society (HS) on the role of direct anterior approach (DAA) contemporary primary total hip arthroplasty (THA). Methods. An online survey was sent to all 112 active and senior members of the HS, to which 71 members responded. The survey was constructed to determine whether they believed that evidence-based medicine proves, in modern clinical practice, that the DAA has significant benefits compared to risks when contrasted with other approaches. In addition, they were asked if they currently used the DAA. Results. While only 16.9% (12/71) of respondents had been trained in a generic anterior approach during residency, 49.3% (35/71) had used the DAA in their clinical practice in the past or were using it at the present time. Unexpectedly, 42.9% (15/35) of respondents who had used the DAA in the past had abandoned it by the time of this survey. Only 22.5% (16/71) of all respondents believed that evidence-based medicine proves that the DAA has significant benefits compared to risks in contrast to other approaches. Conclusion. A comprehensive literature review found only three prospective randomized clinical trials (RCT) comparing the DAA with another approach with greater than one-year follow-up. Two showed minor benefits within the early postoperative period only, and one of those showed poorer mid-term results. Most of the published comparison studies with short follow-up show longer surgical times and greater blood loss for the DAA, and many three-month comparison studies show higher complication rates for the DAA using a proprietary traction table. The complications included problems with wound healing, lateral femoral cutaneous nerve injury, femoral component loosening, and femoral fractures. Because of the lack of evidence from RCTs showing superiority of the DAA over other approaches and reports of higher complications, the opinion of a large majority (77.5%; 55/71) of HS surgeons was that the DAA lacks sufficient evidence to warrant its use. Cite this article: Bone Joint J 2020;102-B(7 Supple B):57–61


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 84 - 84
1 Aug 2020
Kubik J Johal H Kooner S
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The optimal management of rotationally-unstable ankle fractures involving the posterior malleolus remains controversial. Standard practice involves trans-syndesmotic fixation (TSF), however, recent attention has been paid to the indirect reduction of the syndesmosis by repairing small posterior malleolar fracture avulsion fragments, if present, using open reduction internal fixation. Posterior malleolus fixation (PMF) may obviate the need for TSF. Given the limited evidence and diversity in surgical treatment options for rotationally-unstable ankle fractures with ankle syndesmosis and posterior malleolar involvement, we sought to assess the research landscape and identify knowledge gaps to address with future clinical trials. We performed a scoping review to investigate rotational ankle fractures with posterior malleolar involvement, utilizing the framework originally described by Arksey and O'Malley. We searched the English language literature using the Ovid Medline and Embase databases. All study types investigating rotationally-unstable ankle fractures with posterior malleolus involvement were categorized into defined themes and descriptive statistics were used to summarize methods and results of each study. A total of 279 articles published from 1988 to 2018 were reviewed, and 70 articles were included in the final analysis. The literature consists of studies examining the surgical treatment strategies for PMF (n=21 studies, 30%), prognosis of rotational ankle fractures with posterior malleolar involvement (n=16 studies, 23%), biomechanics and fracture pattern of these injuries (n=13 studies, 19%), surgical approach and pertinent anatomy for fixation of posterior malleolus fractures (n=12 studies, 17%), and lastly surgical treatment of syndesmotic injuries with PMF compared to TSF (n=4 studies, 6%). Uncontrolled case series of single treatment made up the majority of all clinical studies (n=44 studies, 63%), whereas controlled study designs were the next most common (n=16 studies, 23%). Majority of research in this field has been conducted in the past eight years (n=52 studies, 74%). Despite increasing concern and debate among the global orthopaedic community regarding rotationally-unstable ankle fractures with syndesmosis and posterior malleolar involvement, and an increasing trend towards PMF, optimal treatment remains unclear when comparing TSF to PMF. Current research priorities are to (1) define the specific injury pattern for which PMF adequately stabilizes the syndesmosis, and (2) conduct a randomized clinical trial comparing PMF to TSF with the assistance of the orthopaedic community at large with well-defined clinical outcomes


Bone & Joint Research
Vol. 9, Issue 6 | Pages 322 - 332
1 Jun 2020
Zhao H Yeersheng R Kang X Xia Y Kang P Wang W

Aims. The aim of this study was to examine whether tourniquet use can improve perioperative blood loss, early function recovery, and pain after primary total knee arthroplasty (TKA) in the setting of multiple-dose intravenous tranexamic acid. Methods. This was a prospective, randomized clinical trial including 180 patients undergoing TKA with multiple doses of intravenous tranexamic acid. One group was treated with a tourniquet during the entire procedure, the second group received a tourniquet during cementing, and the third group did not receive a tourniquet. All patients received the same protocol of intravenous tranexamic acid (20 mg/kg) before skin incision, and three and six hours later (10 mg/kg). The primary outcome measure was perioperative blood loss. Secondary outcome measures were creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events. Results. The mean total blood loss was lowest in the no-tourniquet group at 867.32 ml (SD 201.11), increased in the limited-tourniquet group at 1024.35 ml (SD 176.35), and was highest in the tourniquet group at 1,213.00 ml (SD 211.48). The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001). There was less mean intraoperative blood loss in the tourniquet group (77.48 ml (SD 24.82)) than in the limited-tourniquet group (137.04 ml (SD 26.96)) and the no-tourniquet group (212.99 ml (SD 56.35); both p < 0.001). Patients in the tourniquet group showed significantly higher levels of muscle damage and inflammation biomarkers such as CK, CRP, and IL-6 than the other two groups (p < 0.05). Outcomes for VAS pain scores, limb swelling ratio, quadriceps strength, straight leg raising, ROM, and KSS were significantly better in the no-tourniquet group at three weeks postoperatively (p < 0.05), but there were no significant differences at three months. No significant differences were observed among the three groups with respect to transfusion rate, thrombotic events, or the length of hospital stay. Conclusion. Patients who underwent TKA with multiple doses of intravenous tranexamic acid but without a tourniquet presented lower total blood loss and hidden blood loss, and they showed less postoperative inflammation reaction, less muscle damage, lower VAS pain score, and better early knee function. Our results argue for not using a tourniquet during TKA. Cite this article: Bone Joint Res 2020;9(6):322–332


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 22 - 22
1 Jul 2020
Wong M Buckley R Duffy P Korley R Martin R Harrison T Sanders DW Schneider P Wiens C
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The syndesmosis ligament complex stabilizes the distal tibiofibular joint, while allowing for the subtle fibular motion that is essential for ankle congruity. Flexible fixation with anatomic syndesmosis reduction results in substantial improvements in functional outcomes. New dynamic CT technology allows real-time imaging, as the ankle moves through a range of motion. The aim of this study was to determine if dynamic CT analysis is a feasible method for evaluating syndesmosis reduction and motion following static and flexible syndesmosis fixation. This is a subgroup analysis of a larger multicenter randomized clinical trial, in which patients with AO 44-C injuries were randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5-mm cortical screws, Group S). Surgical techniques and rehabilitation were standardized. Bilateral ankle CT scans were performed at one year post-injury, while patients moved from maximal dorsiflexion (DF) to maximal plantar flexion (PF). Three measurements were taken at one cm proximal to the ankle joint line in maximal DF and maximal PF: anterior, midpoint, and posterior tibiofibular distances. T-tests compared Group T and Group S, and injured and uninjured ankles in each group. Fifteen patients (six Group T [three male], nine Group S [eight male]) were included. There was no difference for mean age (T = 42.8 ± 14.1 years, S = 37 ± 12.6, P = 0.4) or time between injury and CT scan (T = 13 ± 1.8 months, S = 13.2 ± 1.8, P = 0.8). Of note in Group S, seven of nine patients had at least one broken screw and one additional patient had screws removed by the time of their dynamic CT. There was no significant difference between treatment groups for tibiofibular distance measurements in maximal PF or DF. Group T showed no significant difference between the injured and uninjured side for tibiofibular measurements in maximal PF and DF, suggesting anatomic reduction. For Group S, however, there was a significantly larger distance for all three measurements at maximal PF compared to the uninjured ankle (all P < 0 .05). In all but one Group S patient, screws were broken or removed prior to their dynamic CT, allowing possible increased syndesmotic motion, similar to Group T. Despite this, dynamic CT analysis detected increased tibiofibular distance in Group S as ankles moved into maximal PF when compared with the uninjured ankle. Given the importance of anatomic syndesmosis reduction, dynamic ankle CT technology may provide valuable physiologic information warranting further investigation


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 106 - 106
1 Sep 2012
Masri BA Garbuz DS Duncan CP VGreidanus N Bohm E Valle CJD Gross AE
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Purpose. Dislocation after revision total hip is a common complication. The purpose of this study was to assess whether a large femoral head (36/40mm) would result in a decreased dislocation rate compared to a standard head (32mm). Method. A randomized clinical trial was undertaken to assess the effect of large femoral heads on dislocation after revision total hip. Patients undergoing revision hip arthroplasty at seven centers were randomized to 32mm head or 36/40mm head. Patients were stratified according to surgeon. Primary endpoint was dislocation. Rates were compared with Fishers exact test. Secondary outcome measures were quality of life: WOMAC, SF-36 and satisfaction. One hundred eighty four patients were randomized: 92 in the 32mm head group and 92 in the large head group. Baseline demographics were similar in the two groups. Patients were followed from two to five years postoperatively. Results. In the large head group dislocation rate was 1.1% (1/92) versus 8.7% (8/92) for the 32mm head (p=0.035). In this study there was no difference in quality of life between the two groups. Conclusion. This randomized clinical trial demonstrates that a large femoral head (36/40mm) can significantly reduce dislocation rate in patients undergoing revision total hip. As a result of this study the authors now routinely use large heads in all revision hip arthroplasty


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 86 - 86
1 Feb 2020
Khondakar N Shah N Murtaugh T Gold R Aylyarov A Pascal S Harb M Newman J Schwartz J Maheshwari A
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Summary. A meta-analysis was performed to compare rate of SSI after application of chlorhexidine vs. iodine in total joint arthroplasty. Chlorhexidine had significantly lower odds of SSI. Introduction. Surgical site infections (SSI) are a significant source of morbidity and mortality. The optimal preoperative skin preparation in lower extremity total joint arthroplasty (TJA) remains debatable between chlorhexidine and iodine-containing solutions. This meta-analysis sought compare SSI rates between chlorhexidine cloth application the night before surgery plus povidone-iodine-alcohol (povidone-iodine) solution at surgery or only povidone-iodine at surgery. Methods. A structured literature search was performed using Web of Science, PubMed, and EMBASE databases for randomized clinical trials (RCTs) and comparative studies that evaluated preoperative chlorhexidine-gluconate versus iodine-alcohol exclusively in TJA patients. Databases were searched from database inception to January 2, 2018, and studies were included if they had specific aims and 1) compared preoperative chlorhexidine-gluconate cloths to povidone-iodine at surgery, or 2) if they compared preoperative chlorhexidine-gluconate cloths and povidone-iodine at surgery, to solely povidone-iodine at surgery. The main outcome was deep or superficial SSI at or before 1 year postoperatively. If multiple studies reported the same patient cohort, the more recent study was used. To compare the chlorhexidine versus povidone-iodine groups, pooled odds ratios (OR) and 95% confidence intervals (95% CI) were used to calculate odds of SSI. Results. Four studies involving 2,997 TJA patients were included in this meta-analysis. Three were retrospective cohort studies, and one was a RCT. One retrospective cohort study assessed chlorhexidine to povidone-iodine using a historical control. One RCT compared chlorhexidine to povidone-iodine. The remaining two studies compared chlorhexidine in addition to povidone-iodine, to only povidone-iodine. Bias analysis showed low-to-moderate quality cohort studies and one moderate-quality RCT. Chlorhexidine had significantly lower odds of SSI compared to povidone iodine (OR=0.28; 95%CI: 0.15–0.51; p<0.0001). Conclusion. Preoperative chlorhexidine-gluconate was superior at reducing SSI risk in patients who underwent lower extremity TJA, compared to povidone-iodine. This can potentially lead to decreased morbidity and lower surgical revision rates for infections. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 37 - 37
1 Oct 2019
Nahhas CR Chalmers PN Parvizi J Sporer SM Berend KR Moric M Chen AF Austin M Deirmengian GK Morris MJ Culvern C Valle CJD
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Background. The purpose of this multi-center, randomized clinical trial was to compare static and articulating spacers in the treatment of PJI complicating total knee arthroplasty TKA. Methods. 68 Patients treated with two-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. A power analysis determined that 28 patients per group were necessary to detect a 13º difference in range of motion between groups. Six patients were excluded after randomization, six died, and seven were lost to follow-up prior to two years. Results. Patients in the static group had a hospital length of stay that was one day greater than the articulating group (6.1 vs. 5.1 days; p=0.032); no other differences were noted perioperatively. At a mean 3.5 years (range, 2.0 to 6.4 years), 49 patients were available for evaluation. Mean motion arc in the articulating group was 113.0º compared to 100.2º in the static group (p=0.001). The mean Knee Society Score was significantly higher in the articulating cohort (79.4 vs. 69.8 points; p=0.043). Although not significantly different with the sample size studied, static spacers were associated with a greater need for an extensile exposure at the time of reimplantation (16.7% vs. 3.8%) and a higher rate of reoperation (33.3% vs. 12.0%). Conclusions. Articulating spacers provided significantly greater range of motion and better clinical outcomes scores. Static spacers also appeared to affect early postoperative rehabilitation, as evidenced by a longer hospital stay following removal of the infected implant and were associated with a trend towards a greater need for extensile exposures at the time of reimplantation. Further, while it has been commonly believed that static spacers would improve infection control, there was no difference in the failure rate secondary to reinfection and there was a trend towards higher risk of reoperation in patients who received a static spacer. When the soft tissue envelope allows and if there is adequate bony support, an articulating spacer is associated with improved outcomes. For figures, tables, or references, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 73 - 73
1 Oct 2019
Sershon RA Fillingham Y Abdel MP Malkani AL Schwarzkopf R Padgett DE Vail TP Nam D Nahhas CR Culvern C Valle CJD
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Background. The purpose of this multicenter, randomized clinical trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss for revision total hip arthroplasty (THA). Methods. Six centers prospectively randomized 155 revisions to one of four regimens: 1g of intravenous (IV) TXA prior to incision, a double dose regimen of 1g IV TXA prior to incision and 1g IV TXA during wound closure, a combination of 1g IV TXA prior to incision and 1g intraoperative topical TXA, or three doses of 1950mg oral TXA administered 2 hours preoperatively, 6 hours postoperatively, and on the morning of postoperative day one. Randomization was based upon revision subgroups to ensure equivalent group distribution, including: femur only, acetabulum only, both component, explant/spacer, and second stage reimplantation. Patients undergoing an isolated modular exchange were excluded. An a priori power analysis (alpha = 0.05; beta = 0.80) determined 40 patients per group were required to identify a 1g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher's exact tests, and two one-sided t-tests for equivalence. Results. Demographic and surgical variables were equivalent between groups. No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (single IV = 3.6 g/dL, double IV = 3.6 g/dL, combined = 3.4 g/dL, and oral = 3.6 g/dL; p = 0.87), calculated blood loss (p = 0.67), or transfusion rates (single IV = 14%, double IV = 20%, combined = 17%, oral = 21%; p = 0.85). Equivalence testing revealed all possible pairings were statistically equivalent, assuming greater than a 1g/dL difference in hemoglobin reduction as clinically relevant. Conclusions. All TXA regimens tested had equivalent blood-sparing properties in the setting of revision THA. Surgeons should consider the lowest effective dose and the most economical regimen. For any tables or figures, please contact the authors directly


Introduction. There is insufficient data on the trends of anticoagulation after total knee arthroplasty (TKA) in the USA, and the efficacy and safety of rivaroxaban, beyond randomized clinical trials and small cohort studies. Patients and Methods. Using the Truven Health MarketScan database, we retrospectively evaluated new anticoagulation prescriptions after elective TKA from 2010 to 2015. The frequency of deep vein thrombosis (DVT), pulmonary embolism (PE), and adverse events, within 90 days, were then evaluated in 24,856 new users of warfarin and 21,398 new users of rivaroxaban in commercially insured patients (COM), and 15,483 new users of warfarin and 8,997 new users of rivaroxaban in Medicare supplement patients (MED). Data was analyzed by odds ratios using logistic regression models with stabilized inverse probability treatment weighting. Results. Warfarin use decreased from approximately 50% to 17% in COM patients and 60% to 25% in MED patients. Rivaroxaban use increased from 0 to 35% in COM patients and from 0 to 39% in MED patients. Older patients, females, a history of DVT, renal impairment, use of antiplatelet agents or surgery performed as an outpatient had lower odds of getting rivaroxaban. Patients in Western region and having surgery in 2015 had higher odds of getting rivaroxaban. COM patients with capitated insurance plans and a history of PE had lower odds of rivaroxaban initiation. MED patients with atrial fibrillation, cardiovascular disease or hyperlipidemia had lower odds of rivaroxaban initiation. Warfarin users had significantly higher odds ratio of DVT (OR 2.06 in COM patients and OR 2.21 in MED patients) and PE (OR 2.03 in COM patients and OR 2.16 in MED patients) than rivaroxaban users. There were no statistically significant differences in the bleeding risk between the two agents, but warfarin users had a significantly higher odds ratio of periprosthetic infection in both COM (1.57) and MED (1.79) patients. Conclusions. There has been an increase in prophylaxis with rivaroxaban, and a decrease in both warfarin and LMWH use after elective TKA over four years. Rivaroxaban had lower odds ratio of both DVT and PE than warfarin, and bleeding risks were similar. For figures, tables, or references, please contact authors directly


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 13 - 14
1 Mar 2010
McCalden RW Marr JT Bourne RB MacDonald SJ
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Purpose: The purpose of this study is to compare the clinical results of a standard polyethylene tibial insert versus the high flex polyethylene tibial insert component designs of a posterior cruciate substituting total knee replacement. Method: One-hundred patients were entered into a prospective, randomized clinical trial comparing standard polyethylene tibial inserts versus the high flex polyethylene tibial insert component designs of posterior cruciate substituting total knee replacement(Genesis II, Smith & Nephew, Memphis, TN). Patients were evaluated pre-operatively, at 3, 12 months and annually thereafter. Patient demographics, radiographs, and multiple outcome measures (WOMAC, SF-12 and the Knee Society Clinical Rating System) were evaluated. Results: No patients were lost to follow-up. One patient died prior to the two year follow up. Ninety- nine patients were reviewed at an average follow-up of 2.7 years (range 2.3 – 3.1 years). There were no significant differences in any outcome measures or radiographic findings. There were no differences in KSCRS at two years (Standard − 170, High Flex −171). There were no differences in knee flexion at 2 years (Standard− 125°, High Flex − 126°). Conclusion: In this prospective randomized clinical trial, no differences could be seen between standard polyethylene and a “Hi- Flex” polyethylene design at a minimum of 2 years follow-up. In particular, no improvement in knee flexion was observed. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 72 - 72
1 Nov 2018
Racine J
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Exposure to electromagnetic energy has potent signalling effects upon articular cells including chondrocytes, synoviocytes and osteoblasts. Attention has focused on two actions – the altered synthesis of cytokines and enzymes, and the enhanced synthesis of bone and cartilage extracellular matrix (ECM) molecules. In vitro studies with human and bovine articular cartilage have shown increased aggregcan synthesis, glycosaminoglycan content, and biomechanical aggregate modulus with EMF exposure. Osteoarthritic (OA) cartilage responds similarly depending upon the severity of the OA with early OA cartilage responding more robustly. On these bases, two in vivo studies have been done with the Dunkin-Hartley guinea pig model of spontaneous OA. Both studies demonstrated preservation of ECM with increased aggrecan synthesis, matrix glycosaminoglycan and type 2 collagen content, and reduced histological-histochemical (Mankin) scores. Suppression of matrix metalloproteases and IL-1, together with increased TGFb were also observed. Responses to various EMF configurations, in terms of amplitude, frequency, and exposure duration have been described, indicating dose responsiveness. These studies suggest the conclusion that exposure to specific EMFs reduce the progression of early OA. A randomized clinical trial is underway. EMFs may be a disease-modifying therapy for OA, resulting in maintenance of ECM and improvement in the cytokine environment of OA joints


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 25 - 25
1 Mar 2010
McKee MD Thompson C Wild L Schemitsch EH
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Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores. Method: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury. Results: Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p< 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P< 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points. Conclusion: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury. This information is useful in counseling patients with regards to treatment options following displaced fractures of the clavicle shaft


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 77 - 77
1 Mar 2010
Schemitsch E McKee M Thompson C Wild L
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Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores. Materials: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury. Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p> < 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P> < 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points. Conclusions: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 15 - 15
1 Aug 2018
Rolfson O Mohaddes M Rogmark C Kärrholm J Malchau H
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The Swedish Hip Arthroplasty Register started in 1979 and celebrates its 40. th. anniversary in 2019. The Swedish Hip Arthroplasty Register is not primarily a device register or research database; we strive to provide an overall assessment of the care provided with a multidimensional approach, and to disseminate knowledge on best practices in our network of participating hospitals. Since the inception of the register, there has been a marked change in trends and outcomes. The completeness of registrations has been 97–99% for primary THA, 93–95% for revisions, and 95–98% for HA over the last 10 years. The register contains 371,125 primary THAs, 55,893 HAs, 83,233 reoperations, and 408,110 PROM responses registered in 352,585 unique patients. All outcome measures have improved over time; primary THA has 0.71% 90-day mortality, 94.3% 10-year implant survival, and 2.2% 2-year reoperation rate. At 1-year follow up, 91% of the patients report a clinically significant pain reduction, 76% report a substantial improvement in health-related quality of life, and 89% are satisfied with the result of the operation. Moving forward, we are developing enhanced online applications for surgeons, patients and the implant industry to access real-time information. This work involves constructing a shared decision-making tool that helps clinicians assessing the future benefits and risks of THA by offering individualized outcome predictions. Further steps forward include randomized clinical trials and nested studies through the registry's platform. The trends and changes in Swedish arthroplasty practice have largely been promoted and facilitated by the register over the last 40 years


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 43 - 44
1 Mar 2008
MacDonald S Kirkley A Griffin S Ashley J Griffin C
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Patients with moderate to severe osteoarthritis of the knee, on a waiting list for total knearthroplasty, were recruited to a double-blind, randomized clinical trial evaluating neoprene knee braces containing high-power static magnets or sham magnets. Patients wore the brace for a minimum of six hours per day and were evaluated at baseline, two, six, twelve and twenty-four weeks. The subjective outcomes (MACTAR, WOMAC, KOOS, SF-36) and functional outcomes (six minute walk, thirty second stair climb) showed no statistically significant differences between the groups at any of the follow-up time periods. The purpose of this study was to compare the effectiveness of neoprene knee braces containing high-power static magnets to sham magnets in the management of osteoarthritis of the knee. No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups. This study provides patients and doctors with evidence as to the efficacy of this type of therapy. It will allow those individuals on fixed incomes to utilize their resources to the best advantage to minimize their symptoms related to osteoarthritis of the knee. A prospective double-blinded randomized clinical trial was conducted. Ninety-five patients with moderate to severe osteoarthritis of the knee were randomized to receive a Magnet (M) or Sham (S) knee brace. Both groups were equal with regards to age (M = 71.1 yrs, S = 66.8yrs), severity of disease, gender and all baseline measures. No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups at any time interval. All study patients were recruited from a knee arthroplasty waiting list. At baseline and at two, six, twelve and twenty-four weeks each patient completed a WOMAC, MACTAR, KOOS quality-of-life questionnaire, SF–36 global health measure, and six minute walk and thirty second stair climb after which they were asked to determine their general fatigue, pain and shortness of breath on a 100mm VAS scale. Patients were instructed to wear their brace at least six hours per day and when active (walking, shopping, golfing)


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 96 - 97
1 Mar 2008
Bow JK Pittoors K Hunt M Jones I Marr J Bourne R
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This randomized clinical trial compares fixed- and mobile-bearing total knee prostheses in terms of the patients’ clinical outcome parameters (Knee Society Clinical Rating, WOMAC, SF-12), range of motion and performance during gait analysis for level-ground walking. Our results show no significant differences in the clinical outcomes and gait performance of the fixed- and mobile-bearing total knee arthroplasties. The purpose of this study was to compare the clinical outcomes and gait parameters of patients with a fixed-bearing or mobile-bearing total knee arthroplasty (TKA). Fifty-five patients were entered into a prospective, randomized clinical trial comparing fixed- versus mobile-bearing TKAs (Genesis II, Smith & Nephew, Memphis, TN). From this patient population, fifteen fixed-bearing and fifteen mobile-bearing TKA patients were matched based on age, sex and BMI to undergo gait analysis. Patients performed trials of level-ground walking at a self-selected velocity while three-dimensional kinetic and kinematic data were collected. The fixed-bearing and mobile-bearing TKA patient groups were comparable regarding Knee Society Clinical Rating (181 ± 22 versus 171 ± 28), WOMAC scores (7 ± 5 versus 9 ± 12), SF-12 and range of motion (121° ± 11° versus 125° ± 6°). Patients with fixed- and mobile-bearing TKAs performed similarly in the gait analysis in terms of their velocity, percent weight acceptance in the operated versus the non-operated limb, peak flexion in stance and swing phases, the support moments and extension moments at the ankle, knee and hip. Decreased peak extension in the mid-stance and swing phases was observed in the operative limb versus the non-operative limb for both fixed- and mobile-bearing TKAs (P=0.02 and 0.04). Decreased peak extension was also observed during mid-stance and swing phases in the mobile-bearing TKAs versus the fixed-bearing TKAs (P=0.064 and 0.052). Fixed-bearing and mobile-bearing TKAs perform similarly in terms of their clinical outcome measures and the kinetics and kinematics of level-ground walking. Funding for this project obtained from Smith & Nephew, Memphis, TN


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 120 - 120
1 Mar 2008
Mohtadi N Hollinshead R Fletcher J Sasyniuk T
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This randomized clinical trial utilizing the validated rotator cuff disease specific quality of life outcome measure (RC-QOL) and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques. The purpose of the study was to compare standard open rotator cuff repair versus mini-open rotator cuff repair by measuring the disease specific quality of life in patients with rotator cuff injury. This randomized clinical trial utilizing a validated disease specific outcome measure and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques. The miniopen approach utilizing an arthroscoic acromioplasty provides no additional beneifit to the patient undergoing a rotator cuff repair. The mean one year RC-QOL score for the open and mini-open groups were 85.3 (SD = 15.6) and 87.4 (SD = 12.0) out of a maximum of one hundred, respectively. This difference was not statistically significant (p = 0.572). Seventy-two patients (forty-eight males/twenty-four females) with an average age of 56.4 years (thirty-three to eighty-two years) consented to participate in the study. Inclusion criteria involved: unremitting pain, failed conservative treatment of at least three months, weakness of rotator cuff, and positive diagnostic imaging indicating a full-thickness rotator cuff tear. Massive rotator cuff tears were excluded. Prior to surgery, patients were randomized to either open or mini-open rotator cuff repair. Patients were assessed and outcomes were collected at three, six and twelve months after surgery. Primary Outcome Measure: Patient quality of life was quantified using the validated disease specific, reliable and responsive Rotator Cuff Quality of Life Questionnaire (RC-QOL) measured on a one hundred point visual analogue scale format. Secondary Outcomes: Range of motion, strength, American Shoulder and Elbow Surgeons Score, and the Shoulder Rating Questionnaire


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_17 | Pages 88 - 88
1 Dec 2018
Sanders F Backes M Dingemans S Goslings C Schepers T
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Aim. Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. The objective of this trial was to evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Method. This multicenter, double-blind, randomized clinical trial included 500 patients from 19 hospitals with a follow-up of 6 months. Eligible were patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants. Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. The intervention was a single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results. Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7–16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, −1.7 [95% CI, −8.0 to 4.6], P = .60). Conclusions. In patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with placebo did not reduce the risk of surgical site infection within 30 days following implant removal


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 96 - 96
1 Mar 2008
MacDonald S Roabeck C Bourne R McCalden R Cleland D
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Controversy continues to exist regarding the choice of a cementless femoral component in a primary total hip arthroplasty. Both proximally coated tapered stems and fully coated cylindrical stems have excellent clinical results. The incidence of both thigh pain and proximal femoral stress shielding and multiple validated outcome measures were evaluated in a prospective randomized clinical trial with a minimum of two year follow-up comparing a proximally coated tapered femoral stem to a fully coated cylindrical femoral stem. A prospective randomized clinical trial (RCT) was performed comparing a cylindrical cobalt chrome fully coated femoral stem (Prodigy, Depuy, Warsaw, IN) to a tapered, titanium, proximally porous coated stem (Synergy, Smith & Nephew,. Memphis, TN) with respect to thigh pain, femoral stress shielding and multiple outcome measures. One hundred and ninety-four patients were enrolled and evaluations were performed pre-operatively, three months, six months and annually. Multiple outcome measures (Harris Hip Score, SF12, WOMAC, Patient Satisfaction Questionnaire, Thigh Pain Questionnaire) were obtained. Sixty-one of these patients were randomized to receive a bone density scan pre-operatively, two weeks post-operatively, six months and annually. Twelve patients were unavailable for two-year follow-up, leaving one hundred and eighty-two patients evaluated. No significant differences were demonstrated in thigh pain incidence or the multiple outcome measures. Bone density scans demonstrated significantly greater bone density (p< 0.005) in the tapered stem versus the cylindrical stem patients at two-week evaluations from distal femoral reaming. Both stem designs demonstrated statistically significant bone loss in Gruen zones one, six, seven between the two-week and one and two-year evaluations. There were no differences between stem designs although the Prodigy stem demonstrated trends towards greater bone loss in Gruen zones six and seven. This prospective RCT demonstrated no difference in thigh pain incidence and multiple outcome measures between patients receiving a proximally coated tapered versus a fully coated cylindrical femoral component. Both stem designs demonstrated statistically significant proximal femoral bone loss between the post-operative and two-year evaluations; however, there were no differences between stem designs


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 3 - 3
1 Mar 2021
To K Zhang B Romain K Mak CC Khan W
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Abstract. Objective. Articular cartilage damaged through trauma or disease has a limited ability to repair. Untreated, these focal lesions progress to generalized changes including osteoarthritis. Musculoskeletal disorders including osteoarthritis are the most significant contributor to disability globally. There is increasing interest in the use of mesenchymal stem cells (MSCs) for the treatment of focal chondral lesions. There is some evidence to suggest that the tissue type from which MSCs are harvested play a role in determining their ability to regenerate cartilage in vitro and in vivo. In humans, MSCs derived from synovial tissue may have superior chondrogenic potential. Methods. We carried out a systematic literature review on the effectiveness of synovium-derived MSCs (sMSCs) in cartilage regeneration in in vivo studies in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. Nineteen studies were included in our review; four examined the use of human sMSCs and the remainder were conducted using sMSCs harvested from animals. Results. Despite the variability of animals, cell harvesting techniques, methods of delivery, and outcome measures, all studies reported successful cartilage repair with sMSC transplantation. Conclusion. We conclude that sMSC transplantation holds promise as a treatment option for focal cartilage defects. We believe that defining the cell population being used, establishing standardized methods for MSC delivery, and the use of objective outcome measures should enable future high-quality studies such as randomized controlled clinical trials to provide the evidence needed to manage chondral lesions optimally. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 17 - 17
1 Dec 2017
Davies H Blundell C Daniels T Glazebrook M Baumhauer J Younger A Le I Pedersen E
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Introduction. A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. The implant cohort continues to be followed under an extension of the original study and we report on prospectively determined 5+ year outcomes for subjects assessed to date. Methods. Patients treated with hemiarthroplasty implant as part of the previously mentioned trial are eligible for enrollment in the extended study (n=135). At the time of this report, 57 patients had reached the 5+ years postoperative time point, of which 5 were lost to follow-up. The remaining 52 patients with mean age of 58.5 (range, 38.0–0.0) underwent physical examination, radiographic evaluation, assessment of implant survivorship and collection of patient completed VAS pain, and Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale scores. Mean follow-up is 5.8 (range, 4.8–8.4) years. Results. Patient reported pain and function outcome measures showed clinically and statistically meaningful improvements over baseline at 5.8 years. Mean VAS pain scores decreased 57.9 points (86% pain reduction). The mean FAAM Sports and ADL subscale scores increased from baseline 47.9 points (126%) and 32.7 points (55%) respectively. Patients maintained first MTP joint motion with mean active peak MTP dorsiflexion of 25.9° (range, 0–0°) which was a 3° improvement from baseline. Implant survivorship at 5.8 years was 92%; four were converted to fusion because of persistent pain at mean time 42 months post-operation (range, 26–26 months). These results are equivalent to the outcomes reported at 2 years follow-up. 1. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with mid-term evidence of a therapeutic effect and an acceptable safety profile at 5.8 years


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_4 | Pages 28 - 28
1 Apr 2018
Shafizadegan Z Baharlouei H Khoshavi O Garmabi Z Fereshtenejad N
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Background. Balance impairment and falling are of the major health problems in elderly individuals. The ability to maintain standing balance influences the risk of falling while performing everyday activities. Postural control is the base of balance that is the result of collaboration of visual, vestibular and somatosensory systems. Single leg stance test is a simple clinical method to evaluate static balance. In this test, the center of body mass is on a small support level and need to make corrective movements to create balance by postural control system. Kinesiotaping and stretching of ankle plantar flexor muscles used in physical therapy are effective in improvement of postural balance. Kinesiotaping is effective in maintaining balance by activates cutaneous receptors and promoting alpha motor neuron stimulation. Moreover, stretching is a common treatment used to prevent muscle shortness and increase the range of motion that improves the balance. Aim. Therefore the aim of current study was to compare the effects of these two methods in elderly women and men on ankle plantar flexor muscles which are effective to maintain postural status. Materials and Methods. In a single blind randomized clinical trial, 20 elderly male and 20 elderly female were assigned into 2 groups of kinesiotaping and stretching. Inhibitory Y shape tape was applied on the gastrocnemius in first group. In the stretching group, the muscle was stretched for 60 seconds by 4 times. The static balance was examined before and after the interventions by using single leg stance test. In this test, the subjects were asked to stand bare foot on dominant limb and cross their arms over chest. A maximum time for this test is 30 seconds. The researcher who was assessing balance was unaware to the intervention group. Results. According to paired t-test, Despite progress in time to stance on one leg after the interventions, the changes were not significant (P>0.05). Although the trend was more pronounced in the stretching group, independent t-test results showed no significant difference between groups (P>0.05). While in any of the treatment groups, there was no difference between men and women (P=0.1 and P=0.7 for kinesiotaping and stretching group, respectively). Conclusion. While the results did not show any significant difference after the intervention, but Increasing of the test time, which means improving the balance of participants, is evident. However, changes in the stretching group were more pronounced. Keyword. Single leg stance test, Elderly, Stretching, kinesiotaping, Plantar flexor muscle


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 82 - 82
1 Mar 2017
Perreault R Mattingly D Bell CF Talmo C
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Background. Intraoperative blood loss is a known potential complication of total knee arthroplasty (TKA). Tranexamic acid (TXA) has been shown to reduce intraoperative blood loss and postoperative transfusion in patients undergoing TKA. While there are numerous studies demonstrating the efficacy of intravenous and topical TXA in patients undergoing TKA, there are comparatively few demonstrating the effectiveness and appropriate dosing recommendations of oral formulations. Methods. A retrospective cohort study of 2230 TKA procedures at a single institution identified 3 treatment cohorts: patients undergoing TKA without the use of TXA (no-OTA, n=968), patients undergoing TKA with administration of a single-dose of oral TXA (single-dose OTA, n=164), and patients undergoing TKR with administration of preoperative and postoperative oral TXA (two-dose OTA, n=1098). The primary outcome was transfusion rate. Secondary outcomes included maximum postoperative decline in hemoglobin, number of blood units transfused, length of hospital stay, total drain output, cell salvage volume, and operating room time. Results. Transfusion rates decreased from 24.1% in the no-OTA group to 13.6% in the single-dose OTA group (p<0.001) and 11.1% in the two-dose OTA group (p<0.001), with no significant difference in transfusion rates between single- and two-dose OTA groups (p=0.357). Operating room time was reduced from 154 minutes in the no-OTA group to 144 minutes in the one-dose OTA group and 144 minutes in the two-dose OTA group (p<0.01). Additionally, maximum postoperative decline in hemoglobin was reduced from 4.3 g/dL in the no-OTA group to 3.5 g/dL in the single-dose OTA group (p<0.01) and 3.4 g/dL in the two-dose OTA group (p<0.01), without a significant difference between the single- and two-dose regimens (p=0.233). Conclusions. OTA reduces transfusions and operating room time, with the potential advantages of greater ease of administration and improved cost effectiveness relative to other routes of administration. Further study such as a randomized clinical trial is needed to verify the effectiveness of OTA and further optimize dosing regimens in the TKA setting. Level of Evidence. Therapeutic Level III


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 7 - 7
1 Jan 2016
Madadi F
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A group of Athletes with torn ACL (insufficient knees) suffer from bowleg or valgus knees. AT this points we don't have a general consensus in literature. This study is based on a randomized clinical trial with double blind randomization of young athletes not more than 36 years and not over than 82 kg weight. Each groups contained by 30 patient with ACL deficient knees and bowlegs with Mikolicz line on the most medical 1/3rd of medial condyle of femur on worse. with follow up of 2 to 6 years and in all three groups we tried to control the knee by KT 2000, Tegner's score and IKDC and lysholm's scores in all patient. At final exam we had chance to meet 29 patients with simultaneous HTO (open wedge + plate) and ACL – R and 26 patients with HTO 1st, and 6 months later for ACL – R and only 24 patients with ACL – R 1st, 6 patients of this group and a patient of HTO 1st didn't show for rest of their procedures. Conclusion: by P value (o.o1) Simultaneous ACL – R and HTO had higher rate of success and between two other groups except osteoarthritis out come in short period of time (2 – 6 years) HTO had better results than ACL –R 1st with P value of (0.05)


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 77 - 77
1 Mar 2008
Burnett R Haydon C Rorabeck C Bourne R
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The results of a randomized controlled clinical trial of ninety patients comparing resurfacing to non-resurfacing of the patella in total knee arthroplasty (TKA) are reported with a minimum of ten-years of follow-up. Using a cruciate retaining hybrid TKA, the outcome measures included Knee Society Clinical Rating scores, functional testing (stair climb and flexion extension torques), patient satisfaction, anterior knee pain, and a patellofemoral specific questionnaire. The results indicated no difference between the groups in all categories. Results at two and ten years postoperatively are compared. This study represents the longest follow-up to date comparing resurfacing to nonresurfacing of the patella. Patellar resurfacing in TKA remains controversial. Purpose: To evaluate the results of resurfacing/non-resurfacing of the patella in a randomized controlled clinical trial at a minimum of ten-years of follow-up. One hundred knees (ninety patients) with osteoarthritis were enrolled in a prospective randomized controlled double-blinded trial using the same posterior cruciate retaining total knee replacement. Patients were randomized to resurfacing or nonresurfacing of the patella. Evaluations were performed preoperatively and yearly to a minimum ten years (range, 10.1–11.5 years) postoperatively. Disease specific (Knee Society Clinical Rating System), functional (stair climbing, knee flex-ion/extension torques, patellar examination) outcomes were measured. Patient satisfaction, anterior knee pain, and patellofemoral questionnaires were completed. Intraoperative grading of the articular cartilage was performed. No patients were lost to follow-up; forty-six knees remained alive. Nine revisions (9/90-ten percent) were performed – 7/48 (fifteen percent) in the nonresurfaced and 2/42 (five percent) in the resurfaced group. Three knees in the nonresurfaced group were revised to a resurfaced patella for anterior knee pain. One resurfaced patella was complicated by AVN and fracture, requiring revision. No significant difference was found between the groups regarding revision rates, KSCR score, functional, satisfaction, anterior knee pain, patellofemoral, and radiographic outcomes. Intraoperative cartilage quality was not a predictor of outcome. This study represents the longest follow up to date of a randomized controlled clinical trial to examine patellar resurfacing in TKA. The results showed no significant difference between the groups for all outcome measures at a minimum of ten-years


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 81 - 81
1 Mar 2008
Burnett R Haydon C Rorabeck C Bourne R
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The results of a randomized controlled clinical trial of ninety patients comparing resurfacing to non-resurfacing of the patella in total knee arthroplasty (TKA) are reported with a minimum of ten-years of follow-up. Using a cruciate retaining hybrid TKA, the outcome measures included Knee Society Clinical Rating scores, functional testing (stair climb and flexion extension torques), patient satisfaction, anterior knee pain, and a patellofemoral specific questionnaire. The results indicated no difference between the groups in all categories. Results at two and ten years postoperatively are compared. This study represents the longest follow-up to date comparing resurfacing to nonresurfacing of the patella. Patellar resurfacing in TKA remains controversial. Purpose: To evaluate the results of resurfacing/non-resurfacing of the patella in a randomized controlled clinical trial at a minimum of ten-years of follow-up. One hundred knees (ninety patients) with osteoarthritis were enrolled in a prospective randomized controlled double-blinded trial using the same posterior cruciate retaining total knee replacement. Patients were randomized to resurfacing or nonresurfacing of the patella. Evaluations were performed preoperatively and yearly to a minimum ten years (range, 10.1–11.5 years) postoperatively. Disease specific (Knee Society Clinical Rating System), functional (stair climbing, knee flexion/extension torques, patellar examination) outcomes were measured. Patient satisfaction, anterior knee pain, and patellofemoral questionnaires were completed. Intraoperative grading of the articular cartilage was performed. No patients were lost to follow-up; forty-six knees remained alive. Nine revisions (9/90-ten percent) were performed – 7/48 (fifteen percent) in the nonresurfaced and 2/42 (five percent) in the resurfaced group. Three knees in the nonresurfaced group were revised to a resurfaced patella for anterior knee pain. One resurfaced patella was complicated by AVN and fracture, requiring revision. No significant difference was found between the groups regarding revision rates, KSCR score, functional, satisfaction, anterior knee pain, patellofemoral, and radiographic outcomes. Intraoperative cartilage quality was not a predictor of outcome. This study represents the longest follow up to date of a randomized controlled clinical trial to examine patellar resurfacing in TKA. The results showed no significant difference between the groups for all outcome measures at a minimum of ten-years


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 57 - 57
1 Dec 2016
Rezapoor M Tan T Maltenfort M Chen A Parvizi J
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Aim. Different perioperative strategies have been implemented to reduce the devastating burden of infection following arthroplasty. The use of iodophor-impregnated adhesive incise drapes is one such strategy. Despite its wide adoption, there is little proof that this practice leads to a reduction of bacterial colonization. The aim of this randomized, prospective study was to evaluate the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count at the incision site. Method. A total of 96 patients undergoing open joint preservation procedure of the hip were enrolled in this prospective, randomized clinical trial of iodophor-impregnated adhesive drapes. *. One half of patients (n=48) had iodophor-impregnated adhesive drapes. *. applied to the skin prior to incision and kept on throughout the procedure, while the other half (n=48) underwent the same surgery without the use of iodophor-impregnated adhesive drapes. *. Culture swabs were taken from the surgical site at five different time points during surgery (pre-skin preparation, after skin preparation, post-incision, before subcutaneous closure, and prior to dressing application) and sent for culture and colony counts. Mixed-effects and multiple logistic regression analyses were utilized. Results. Iodophor-impregnated adhesive drapes resulted in a significant reduction of bacterial colonization of the surgical incision. At the conclusion of surgery, 12.5% (6/48) of incisions with iodophor-impregnated adhesive drapes. *. and 27.0% (13/48) without adhesive drapes were positive for bacteria. When controlling for preoperative colonization and other factors, patients without adhesive drapes were significantly more likely to have bacteria present at the incision at the time of closure (odds ratio (OR) 11.88, 95% confidence interval (CI) 1.45–80.00), and at all time-points when swab cultures were taken (OR 2.48, 95% CI 1.00–6.15). Conclusions. Based on this skin sampling study, incise draping significantly reduces the rate of bacterial colonization/contamination during hip surgery. The bacterial count at the skin was extremely high in some patients without iodophor-impregnated adhesive drapes. *. , which raises the possibility that a subsequent surgical site infection or periprosthetic joint infection could likely arise if an implant had been utilized


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 79 - 79
1 Dec 2013
Iannotti J
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Accurate implant placement is important to the success of joint replacement surgery. Three dimensional pre-operative planning optimizing the ability to define the anatomy and select the desired implant and its location. Linking this information into implant and patient specific instrumentation has been termed smart instrumentation. Single use instruments contain the patient's topographical boney anatomy and implant information. This same information can be placed within a bone model and a reusable instrument placed onto the bone model can be adjusted to capture the information originally in the planning software. This instrument can then be placed into the surgical site, registered to the bone surfaces and used to modify the bone surfaces to replicate the surgical plan. These concepts, technology and devices have been developed and clinically tested in randomized clinical trials for shoulder arthroplasty


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 75 - 75
1 Mar 2008
MacDonald S Marr J Bourne R McCalden R Rorabeck C
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Fixed bearing and mobile bearing knee designs are both currently used in clinical practice with little evidence- based research available to determine superiority of one system. We performed a prospective, randomized, blinded clinical trial to compare a mobile bearing to two standard fixed bearing implants. A single observer was used to measure all range of motion scores. We evaluated the short and long- term outcomes of the SAL. ®. (mobile bearing) versus the AMK. ®. and Genesis II. ®. (fixed bearings) total knee joint replacements. Minimum two- year follow-up revealed no differences in the outcome measures (WOMAC, SF-12, Knee Society Clinical Rating System). The purpose of this study was to compare the results between a cruciate retaining mobile bearing total knee (SAL. ®. , Sulzer) and two cruciate retaining fixed bearing total knee prostheses (AMK. ®. , Depuy and Genesis II. ®. , Smith and Nephew). Ninety patients were randomized to receive a SAL, AMK, or GenesisII prostheses. Patients were evaluated pre-operatively, at three, twelve months and annually thereafter. Patient demographics, radiographs, and multiple outcome measures (WOMAC, SF-12 and the Knee Society Clinical Rating System) were evaluated. No patients were lost to follow-up. One patient was withdrawn due to dementia before three months, one patient died prior to the two year follow up, and one patient was revised for infection at 6 months leaving eighty-seven patients at an average follow-up of 3.37 years (range 2.91 – 4.44 years). There were no significant differences in any outcome measures or radiographic findings. There were no differences in KSCRS at two years (SAL - 167, AMK – 158, GenesisII – 166). There were no differences in knee flexion at two years (SAL – 117. °. , AMK – 115. °. , GenesisII – 118. °. ). No differences in multiple outcome measures were seen between a cruciate retaining mobile bearing and two cruciate retaining fixed bearing total knee prostheses. In this prospective randomized clinical trial no differences could be seen between a mobile bearing and two fixed bearing designs at a minimum of two years follow-up. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity. Funding: London Health Sciences Centre Internal Research Fund


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 79 - 79
1 Mar 2008
MacDonald S Marr J Bourne R McCalden R Rorabeck C
Full Access

Fixed bearing and mobile bearing knee designs are both currently used in clinical practice with little evidence- based research available to determine superiority of one system. We performed a prospective, randomized, blinded clinical trial to compare a mobile bearing to two standard fixed bearing implants. A single observer was used to measure all range of motion scores. We evaluated the short and long- term outcomes of the SAL. ®. (mobile bearing) versus the AMK. ®. and Genesis II. ®. (fixed bearings) total knee joint replacements. Minimum two- year follow-up revealed no differences in the outcome measures (WOMAC, SF-12, Knee Society Clinical Rating System). The purpose of this study was to compare the results between a cruciate retaining mobile bearing total knee (SAL. ®. , Sulzer) and two cruciate retaining fixed bearing total knee prostheses (AMK. ®. , Depuy and Genesis II. ®. , Smith and Nephew). Ninety patients were randomized to receive a SAL, AMK, or GenesisII prostheses. Patients were evaluated pre-operatively, at three, twelve months and annually thereafter. Patient demographics, radiographs, and multiple outcome measures (WOMAC, SF-12 and the Knee Society Clinical Rating System) were evaluated. No patients were lost to follow-up. One patient was withdrawn due to dementia before three months, one patient died prior to the two year follow up, and one patient was revised for infection at 6 months leaving eighty-seven patients at an average follow-up of 3.37 years (range 2.91 – 4.44 years). There were no significant differences in any outcome measures or radiographic findings. There were no differences in KSCRS at two years (SAL - 167, AMK – 158, GenesisII – 166). There were no differences in knee flexion at two years (SAL – 117. °. , AMK – 115. °. , GenesisII – 118. °. ). No differences in multiple outcome measures were seen between a cruciate retaining mobile bearing and two cruciate retaining fixed bearing total knee prostheses. In this prospective randomized clinical trial no differences could be seen between a mobile bearing and two fixed bearing designs at a minimum of two years follow-up. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity. Funding: London Health Sciences Centre Internal Research Fund


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 63 - 63
1 May 2016
Colombo M Calori G Mazza E Mazzola S Minoli C
Full Access

INTRODUCTION. The hip arthroplasty implant is currently growing up both in orthopedic and trauma practice. This increases the frequency of prosthesis revision due to implant loosening often associated with periprosthetic osteolysis that determine the failure and lead to a loss of bone substance. Nowadays there are numerous biotechnologies seeking to join or substitute the autologous or omologous bone use. These biotechnologies (mesenchymal stromal cells, growth factors and bone substitutes) may be used in such situations, however, the literature doesn't offer class 1 clinical evidences in this field of application. MATERIALS AND METHODS. We performed a literature review using the universally validated search engines in the biomedical field: PubMed / Medline, Google Scholar, Scopus, EMBASE. The keywords used were: “Growth Factors”, “Platelet Rich Plasma”, “OP-1”, “BMP”, “BMP-2”, “BMP-7”, “Demineralized Bone Matrix”, “Stem Cell”, “Bone Marrow”, “Scaffold”, “Bone Substitutes” were crossed with “hip”, “revision”, “replacement” / “arthroplasty”, “bone loss” / “osteolysis.”. RESULTS. The search led to 321 items, of these were considered relevant: as regards the growth factors 21 articles related to in vivo animal studies and 2 articles of human clinical use of BMPs and 1 single article on the use of PRP; as regards the mesenchymal stromal cells 2 items of application in animals; as regards the use of bone substitutes we have analyzed a review of this application. DISCUSSION. The use of biotechnologies in hip prosthetic revisions has produced conflicting results: autologous growth factors (PRP) have definitely been proven effective in maxillofacial surgery, in animal studies the results of BMPs are inconsistent with articles that validate their use and others that don't recommend it. Clinical application has demonstrated, today, the limited use of BMP-7 in revisions with even an increased risk of early re-mobilization, PRP appears to be rather effective only in the early stages of peri-prosthetic osteolysis. The mesenchymal cells can increase the chances of recovery and integration of the grafts but an important variable is the number of cells that are still alive after the impaction of the graft which affects their vitality. The bone substitutes appear to be safe and very useful, particularly if applied in order to implement the omologous bone, which is still the most scaffolds used in this surgery. CONCLUSIONS. The systematic review of the literature has shown an important lack of clinical studies regarding the use of biotechnologies for prosthetic revisions. It is therefore difficult to draw guidelines that regulate the application, prospective randomized clinical studies are therefore needed to validate its effectiveness


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 132 - 132
1 Jun 2012
Madadi F
Full Access

Suction drains provide an easy and feasible method for controlling hemorrhage after total knee arthroplasty. However, there has been no compromise regarding the optimal clamping time for these drains. We conducted a randomized clinical trial to compare 12-hour drain clamping and continuous drainage after total knee arthroplasty in terms of wound complications, blood loss and articular range of motion. In order to eliminate any other factor except duration of clamping, we chose to compare knees belonging to one single person, as well as restricting the study to those knees undergoing surgery due to osteoarthritis. From a total of 100 knees (50 patients) studied, the 12-hour clamping method resulted in a significantly smaller amount of post-operative blood loss (p<0.001). The passive ranges of motion and wound complications were not significantly different between the two groups


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 6 - 6
1 Jan 2016
Madadi F
Full Access

High tibial osteotomy generally helps patients to postpone the TKA or even stay in peace for rest of their life, but sometimes these procedures enhance the process of osteoarthritis (1) several reasons like unhealthy lateral compartment of the knee or age or weight or concomitant debilitating diseases could be included in account. In this study we focused on those patients that were selected properly with correct procedure but still shows the knee OA enhancement. Hypothesis: probably bone bruise around the site of osteotomy as trauma of surgery can make a bad condition. As a RCT study between 2 groups with different technique of osteotomy especially the distance of osteotomy site from the joint line of proximal tibia was our main reason to choose the different procedures. We did a randomized clinical trial with not more than a year follow up and mostly emphasis in geometry of bone bruise around osteotomy site. Group A: 50 knees, open wedge and plate technique. Group B: reversed-v MIS the same 50 other knees (FM). Method: All patient asked for MRI before and in 1st 10 days post surgery from their target knees. Those with positive bone bruise sign before surgery were excluded. In post op MRIs we measured the geometry of bone bruise. 1- Our finding shows upward-downward length of bone bruise in MIS (F.M) reversed-v = 14–40 mm and in open wedge = 14–37 mm. Depth (Medial-lateral) and AP diameter almost the same. 2- To omit the bias of bone bruise around the open wedge technique we ignored this part. Result and conclusion:. Group A: had 14 – 40 mm bone bruise that in 61% reached to sub chondral bone (distance of osteotomy's site from sub chondral bone). Area was (17−4mm). Group B: because of the distance of osteotomy site from joint line were 60–70 mm. in no one bone bruise was closer than 26mm to sub chondral bone. So, our Iatrogenic bone bruise from joint line in reversed - v is in safer zone than open wedge and plating with p. value of 0.0001. In future we need to follow our patients to be sure if bone bruise makes any hazard for the knees


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 64 - 64
1 Jan 2016
Calori G Colombo M Mazzola S Malagoli E
Full Access

INTRODUCTION. The hip arthroplasty implant is currently growing up both in orthopedic and trauma practice. This increases the frequency of prosthesis revision due to implant loosening often associated with periprosthetic osteolysis that determine the failure and lead to a loss of bone substance. Nowadays there are numerous biotechnologies seeking to join or substitute the autologous or omologous bone use. These biotechnologies (mesenchymal stromal cells, growth factors and bone substitutes) may be used in such situations, however, the literature doesn't offer class 1 clinical evidences in this field of application. MATERIALS AND METHODS. We performed a literature review using the universally validated search engines in the biomedical field: PubMed / Medline, Google Scholar, Scopus, EMBASE. The keywords used were: “Growth Factors”, “Platelet Rich Plasma”, “OP-1”, “BMP”, “BMP-2”, “BMP-7”, “Demineralized Bone Matrix”, “Stem Cell”, “Bone Marrow”, “Scaffold”, “Bone Substitutes” were crossed with “hip”, “revision”, “replacement” / “arthroplasty”, “bone loss” / “osteolysis.”. RESULTS. The search led to 321 items, of these were considered relevant: as regards the growth factors 21 articles related to in vivo animal studies and 2 articles of human clinical use of BMPs and 1 single article on the use of PRP; as regards the mesenchymal stromal cells 2 items of application in animals; as regards the use of bone substitutes we have analyzed a review of this application. DISCUSSION. The use of biotechnologies in hip prosthetic revisions has produced conflicting results: autologous growth factors (PRP) have definitely been proven effective in maxillofacial surgery, in animal studies the results of BMPs are inconsistent with articles that validate their use and others that don't recommend it. Clinical application has demonstrated, today, the limited use of BMP-7 in revisions with even an increased risk of early re-mobilization, PRP appears to be rather effective only in the early stages of peri-prosthetic osteolysis. The mesenchymal cells can increase the chances of recovery and integration of the grafts but an important variable is the number of cells that are still alive after the impaction of the graft which affects their vitality. The bone substitutes appear to be safe and very useful, particularly if applied in order to implement the omologous bone, which is still the most scaffolds used in this surgery. CONCLUSIONS. The systematic review of the literature has shown an important lack of clinical studies regarding the use of biotechnologies for prosthetic revisions. It is therefore difficult to draw guidelines that regulate the application, prospective randomized clinical studies are therefore needed to validate its effectiveness


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 319 - 322
1 Apr 2024
Parsons N Whitehouse MR Costa ML


Bone & Joint Open
Vol. 4, Issue 6 | Pages 442 - 446
12 Jun 2023
Toda Y Iwata S Kobayashi E Ogura K Osaki S Fukushima S Mawatari M Kawai A

Aims

The risk of postoperative complications after resection of soft-tissue sarcoma in the medial thigh is higher than in other locations. This study investigated whether a vessel sealing system (VSS) could help reduce the risk of postoperative complications after wide resection of soft-tissue sarcoma in the medial thigh.

Methods

Of 285 patients who underwent wide resection for soft-tissue sarcoma between 2014 and 2021 at our institution, 78 patients with tumours in the medial thigh were extracted from our database. Information on clinicopathological characteristics, preoperative treatment, surgical treatment (use of VSS, blood loss volume, operating time), and postoperative course (complications, postoperative haemoglobin changes, total drainage volume, and drainage and hospitalization durations) were obtained from medical records. We statistically compared clinical outcomes between patients whose surgery did or did not use VSS (VSS and non-VSS groups, respectively).


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 209 - 214
1 Feb 2023
Aarvold A Perry DC Mavrotas J Theologis T Katchburian M

Aims

A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening.

Methods

A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group.


Bone & Joint 360
Vol. 11, Issue 5 | Pages 34 - 36
1 Oct 2022


Bone & Joint 360
Vol. 12, Issue 6 | Pages 17 - 20
1 Dec 2023

The December 2023 Hip & Pelvis Roundup360 looks at: Early hip fracture surgery is safe for patients on direct oral anticoagulants; Time to return to work by occupational class after total hip or knee arthroplasty; Is there a consensus on air travel following hip and knee arthroplasty?; Predicting whether patients will achieve minimal clinically important differences following hip or knee arthroplasty; High-dose dual-antibiotic-loaded cement for hip hemiarthroplasty in the UK (WHiTE 8): a randomized controlled trial; Vitamin E – a positive thing in your poly?; Hydroxapatite-coated femoral stems: is there a difference in fixation?


Bone & Joint 360
Vol. 12, Issue 6 | Pages 27 - 31
1 Dec 2023

The December 2023 Wrist & Hand Roundup360 looks at: Volar locking plate for distal radius fractures with patient-reported outcomes in older adults; Total joint replacement or trapeziectomy?; Replantation better than revision amputation in traumatic amputation?; What factors are associated with revision cubital tunnel release within three years?; Use of nerve conduction studies in carpal tunnel syndrome; Surgical site infection following surgery for hand trauma: a systematic review and meta-analysis; Association between radiological and clinical outcomes following distal radial fractures; Reducing the carbon footprint in carpal tunnel surgery inside the operating room with a lean and green model: a comparative study.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 795 - 800
1 Jul 2023
Parsons N Achten J Costa ML

Aims

To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial.

Methods

The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 356 - 360
15 Mar 2023
Baker PN Jeyapalan R Jameson SS

The importance of registries has been brought into focus by recent UK national reports focusing on implant (Cumberlege) and surgeon (Paterson) performance. National arthroplasty registries provide real-time, real-world information about implant, hospital, and surgeon performance and allow case identification in the event of product recall or adverse surgical outcomes. They are a valuable resource for research and service improvement given the volume of data recorded and the longitunidal nature of data collection. This review discusses the current value of registry data as it relates to both clinical practice and research.

Cite this article: Bone Joint J 2023;105-B(4):356–360.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 99 - 99
1 May 2016
van de Groes S Kreemers-Van De Hei K Koeter S Verdonschot N
Full Access

Introduction. Special high-flexion prosthetic designs show a small increase in postoperative flexion compared to standard designs and some papers show increased anterior knee pain with these prosthesis. However, no randomised controlled trails have been published which investigate difference in postoperative complaints of anterior knee pain. To assess difference in passive and active postoperative flexion and anterior knee pain we performed a randomized clinical trial including the two extremes of knee arthroplasty designs, being a high flex posterior stabilized rotating platform prosthesis versus a traditional cruciate retaining fixed bearing prosthesis. We hypothesised that the HF-PS design would allow more flexion, due to increased femoral rollback with less anterior knee pain than the CR design. We specifically assessed the following hypotheses:. Patients have increased flexion after HF-PS TKA compared to CR TKA, both passive and active. Patients show an increased femoral rollback in the HF-PS TKA as compared to the CR TKA. Patients receiving a HF-PS TKA design report reduced anterior knee pain relative to those receiving the CR TKA. Methods. In total 47 patients were randomly allocated to a standard cruciate retaining fixed bearing design (CR) in 23 patients and to a high-flexion posterior stabilized mobile bearing design (HF-PS) in 24 patients. Preoperative and one year postoperative we investigated active and passive maximal flexion. Furthermore, we used the VAS pain score at rest and during exercise and the Feller score to investigate anterior knee pain. A lateral roentgen photograph was used to measure femoral rollback during maximal flexion. Results. The HF-PS did show a significantly higher passive postoperative flexion; 120.8° (SD 10.3°) vs. 112.0° (SD 9.5°) for the CR group (p=0.004). The active postoperative flexion, VAS-pain score and Feller score did not show significant differences between both groups. Sub analysis with the HF-PS group showed a higher VAS-pain for the patients achieving ≥130° of flexion; 30.5 (SD 32.2) vs. 12.2 (SD 12.5) (p=0.16). The rollback was significantly lower in the CR group compared to the HF-PS group; 4.4 (SD 3.0) vs. 8.4 (SD 2.1). Conclusion. The present study showed a significant higher passive flexion in the Posterior Stabilised-High Flexion mobile bearing compared to a Cruciate Retaining fixed bearing prosthesis. However, this difference disappeared when comparing active flexion. The difference in passive flexion was probably related to a significantly lower rollback causing impingement in the CR prosthesis. No difference in anterior knee pain was found between both groups. However, a suggestion is raised that achieving high-flexion might lead to more patellofemoral complaints/anterior knee pain


Bone & Joint 360
Vol. 13, Issue 4 | Pages 19 - 23
2 Aug 2024

The August 2024 Foot & Ankle Roundup360 looks at: ESWT versus surgery for fifth metatarsal stress fractures; Minimally invasive surgery versus open fusion for hallux rigidus; Diabetes and infection risk in total ankle arthroplasty; Is proximal medial gastrocnemius recession useful for managing chronic plantar fasciitis?; Fuse the great toe in the young!; Conservative surgery for diabetic foot osteomyelitis; Mental health and outcome following foot and ankle surgery.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 729 - 735
3 Sep 2024
Charalambous CP Hirst JT Kwaees T Lane S Taylor C Solanki N Maley A Taylor R Howell L Nyangoma S Martin FL Khan M Choudhry MN Shetty V Malik RA

Aims

Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space.

Methods

The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 254 - 260
1 Mar 2023
Bukowski BR Sandhu KP Bernatz JT Pickhardt PJ Binkley N Anderson PA Illgen R

Aims

Osteoporosis can determine surgical strategy for total hip arthroplasty (THA), and perioperative fracture risk. The aims of this study were to use hip CT to measure femoral bone mineral density (BMD) using CT X-ray absorptiometry (CTXA), determine if systematic evaluation of preoperative femoral BMD with CTXA would improve identification of osteopenia and osteoporosis compared with available preoperative dual-energy X-ray absorptiometry (DXA) analysis, and determine if improved recognition of low BMD would affect the use of cemented stem fixation.

Methods

Retrospective chart review of a single-surgeon database identified 78 patients with CTXA performed prior to robotic-assisted THA (raTHA) (Group 1). Group 1 was age- and sex-matched to 78 raTHAs that had a preoperative hip CT but did not have CTXA analysis (Group 2). Clinical demographics, femoral fixation method, CTXA, and DXA data were recorded. Demographic data were similar for both groups.


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 17 - 24
1 May 2024
Anderson LA Wylie JD Kapron C Blackburn BE Erickson JA Peters CL

Aims

Periacetabular osteotomy (PAO) is the preferred treatment for symptomatic acetabular dysplasia in adolescents and young adults. There remains a lack of consensus regarding whether intra-articular procedures such as labral repair or improvement of femoral offset should be performed at the time of PAO or addressed subsequent to PAO if symptoms warrant. The purpose was to determine the rate of subsequent hip arthroscopy (HA) in a contemporary cohort of patients, who underwent PAO in isolation without any intra-articular procedures.

Methods

From June 2012 to March 2022, 349 rectus-sparing PAOs were performed and followed for a minimum of one year (mean 6.2 years (1 to 11)). The mean age was 24 years (14 to 46) and 88.8% were female (n = 310). Patients were evaluated at final follow-up for patient-reported outcome measures (PROMs). Clinical records were reviewed for complications or subsequent surgery. Radiographs were reviewed for the following acetabular parameters: lateral centre-edge angle, anterior centre-edge angle, acetabular index, and the alpha-angle (AA). Patients were cross-referenced from the two largest hospital systems in our area to determine if subsequent HA was performed. Descriptive statistics were used to analyze risk factors for HA.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 680 - 687
1 Jul 2024
Mancino F Fontalis A Grandhi TSP Magan A Plastow R Kayani B Haddad FS

Aims

Robotic arm-assisted surgery offers accurate and reproducible guidance in component positioning and assessment of soft-tissue tensioning during knee arthroplasty, but the feasibility and early outcomes when using this technology for revision surgery remain unknown. The objective of this study was to compare the outcomes of robotic arm-assisted revision of unicompartmental knee arthroplasty (UKA) to total knee arthroplasty (TKA) versus primary robotic arm-assisted TKA at short-term follow-up.

Methods

This prospective study included 16 patients undergoing robotic arm-assisted revision of UKA to TKA versus 35 matched patients receiving robotic arm-assisted primary TKA. In all study patients, the following data were recorded: operating time, polyethylene liner size, change in haemoglobin concentration (g/dl), length of inpatient stay, postoperative complications, and hip-knee-ankle (HKA) alignment. All procedures were performed using the principles of functional alignment. At most recent follow-up, range of motion (ROM), Forgotten Joint Score (FJS), and Oxford Knee Score (OKS) were collected. Mean follow-up time was 21 months (6 to 36).


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 986 - 993
1 Sep 2024
Hatano M Sasabuchi Y Isogai T Ishikura H Tanaka T Tanaka S Yasunaga H

Aims

The aim of this study was to compare the early postoperative mortality and morbidity in older patients with a fracture of the femoral neck, between those who underwent total hip arthroplasty (THA) and those who underwent hemiarthroplasty.

Methods

This nationwide, retrospective cohort study used data from the Japanese Diagnosis Procedure Combination database. We included older patients (aged ≥ 60 years) who underwent THA or hemiarthroplasty after a femoral neck fracture, between July 2010 and March 2022. A total of 165,123 patients were included. The THA group was younger (mean age 72.6 (SD 8.0) vs 80.7 years (SD 8.1)) and had fewer comorbidities than the hemiarthroplasty group. Patients with dementia or malignancy were excluded because they seldom undergo THA. The primary outcome measures were mortality and complications while in hospital, and secondary outcomes were readmission and reoperation within one and two years after discharge, and the costs of hospitalization. We conducted an instrumental variable analysis (IVA) using differential distance as a variable.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 284 - 293
1 Mar 2023
Li Y Zhang X Ji B Wulamu W Yushan N Guo X Cao L

Aims

Gram-negative periprosthetic joint infection (PJI) has been poorly studied despite its rapidly increasing incidence. Treatment with one-stage revision using intra-articular (IA) infusion of antibiotics may offer a reasonable alternative with a distinct advantage of providing a means of delivering the drug in high concentrations. Carbapenems are regarded as the last line of defense against severe Gram-negative or polymicrobial infection. This study presents the results of one-stage revision using intra-articular carbapenem infusion for treating Gram-negative PJI, and analyzes the characteristics of bacteria distribution and drug sensitivity.

Methods

We retrospectively reviewed 32 patients (22 hips and 11 knees) who underwent single-stage revision combined with IA carbapenem infusion between November 2013 and March 2020. The IA and intravenous (IV) carbapenem infusions were administered for a single Gram-negative infection, and IV vancomycin combined with IA carbapenems and vancomycin was applied for polymicrobial infection including Gram-negative bacteria. The bacterial community distribution, drug sensitivity, infection control rate, functional recovery, and complications were evaluated. Reinfection or death caused by PJI was regarded as a treatment failure.


Bone & Joint Research
Vol. 11, Issue 11 | Pages 826 - 834
17 Nov 2022
Kawai T Nishitani K Okuzu Y Goto K Kuroda Y Kuriyama S Nakamura S Matsuda S

Aims

The preventive effects of bisphosphonates on articular cartilage in non-arthritic joints are unclear. This study aimed to investigate the effects of oral bisphosphonates on the rate of joint space narrowing in the non-arthritic hip.

Methods

We retrospectively reviewed standing whole-leg radiographs from patients who underwent knee arthroplasties from 2012 to 2020 at our institute. Patients with previous hip surgery, Kellgren–Lawrence grade ≥ II hip osteoarthritis, hip dysplasia, or rheumatoid arthritis were excluded. The rate of hip joint space narrowing was measured in 398 patients (796 hips), and the effects of the use of bisphosphonates were examined using the multivariate regression model and the propensity score matching (1:2) model.


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 603 - 612
1 Jun 2024
Ahmad A Egeland EH Dybvik EH Gjertsen J Lie SA Fenstad AM Matre K Furnes O

Aims

This study aimed to compare mortality in trochanteric AO/OTA A1 and A2 fractures treated with an intramedullary nail (IMN) or sliding hip screw (SHS). The primary endpoint was 30-day mortality, with secondary endpoints at 0 to 1, 2 to 7, 8 to 30, 90, and 365 days.

Methods

We analyzed data from 26,393 patients with trochanteric AO/OTA A1 and A2 fractures treated with IMNs (n = 9,095) or SHSs (n = 17,298) in the Norwegian Hip Fracture Register (January 2008 to December 2020). Exclusions were made for patients aged < 60 years, pathological fractures, pre-2008 operations, contralateral hip fractures, fractures other than trochanteric A1/A2, and treatments other than IMNs or SHSs. Kaplan-Meier and Cox regression analyses adjusted for type of fracture, age, sex, cognitive impairment, American Society of Anesthesiologists (ASA) grade, and time period were conducted, along with calculations for number needed to harm (NNH).


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 895 - 904
1 Aug 2023
Smith TO Dainty J Loveday DT Toms A Goldberg AJ Watts L Pennington MW Dawson J van der Meulen J MacGregor AJ

Aims

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures.

Methods

Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 347 - 355
15 Mar 2023
Birch NC Cheung JPY Takenaka S El Masri WS

Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents.

Cite this article: Bone Joint J 2023;105-B(4):347–355.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1073 - 1080
1 Sep 2022
Winstanley RJH Hadfield JN Walker R Bretherton CP Ashwood N Allison K Trompeter A Eardley WGP

Aims

The Open-Fracture Patient Evaluation Nationwide (OPEN) study was performed to provide clarity in open fracture management previously skewed by small, specialist centre studies and large, unfocused registry investigations. We report the current management metrics of open fractures across the UK.

Method

Patients admitted to hospital with an open fracture (excluding phalanges or isolated hand injuries) between 1 June 2021 and 30 September 2021 were included. Institutional information governance approval was obtained at the lead site and all data entered using Research Electronic Data Capture software. All domains of the British Orthopaedic Association Standard for Open Fracture Management were recorded.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 53 - 53
1 Jan 2016
Brown G
Full Access

Significance. In ideal shared decision making (SDM), evidence-based treatment options, their likelihood of success, and the probability of adverse events is discussed with the patient. However, current SDM is fundamentally flawed because evidence for patient-specific treatment effectiveness and patient-specific adverse event risks is lacking. Observational outcome registries are better than randomized clinical trials for determining patient prognostic factors for outcomes and adverse events. No orthopaedic SDM clinical tools exist to predict patient-specific outcomes. Hypothesis: A patient-specific shared decision making tool can predict clinically significant outcomes and adverse events for total knee replacement (TKR) surgery. Methods. A web–based prospective observational outcome registry collects patient reported outcomes (PROs) for TKR surgery. The data set for TKR surgery includes: (1) European quality of life (EQ-5D); (2) Oxford Knee Score (OKS); (3) Lower Extremity Activity Scale (LEAS); and (4) Pain Likert Scale (PLS). A TKR outcome calculator predicts patient-specific functional outcome with a regression model using patient-specific pre-operative Oxford Knee Scores, diagnosis, co-morbidities, and demographics. Patient-specific joint infection relative risk is calculated using diagnosis, co-morbidities, and demographics. Functional outcomes are presented as minimum clinically important differences (MCIDs). MCID=σ. Δ. /2. Results. The MCID for the EQ-5D Health State Score (HSS) is 0.094 (0.000–1.000). The MCID for the EQ-5D Visual Analog Scale (VAS) is 9.1 (0–100). The MCID for the OKS is 4.45 (0–48). The MCID for the LEAS is 1.6 (1–18). The MCID for the PLS is 1.4 (0–10). Examples. (1) A 55-year-old white male with post-traumatic arthritis (ICD-9 716.16, BMI = 28.7, non-diabetic, recently quit smoking) has a pre-operative Oxford Knee Score of 10. His predicted outcome is 6.3 MCIDs and his relative risk of infection is 6.1 (4.4%) (Figure 1). He is expected to have an excellent outcome. His risk of infection can be reduced by using antibiotic-laden cement. Depending on the patient's preferences, he is an excellent candidate for a total knee replacement. (2) A 60-year-old white male with osteoarthritis (ICD-9 715.16, BMI = 25.0, non-diabetic, non-smoker) has a pre-operative Oxford Knee Score of 45. He has full thickness cartilage loss on his medial femoral condyle by MRI only. His predicted outcome is 0.67 MCIDs and his relative risk of infection is 1.9 (1.4%) (Figure 2). He is expected to have a poor outcome even though his risk of infection is low. Although he has full thickness cartilage loss on MRI, his pre-operative Oxford Knee Score of 45 demonstrates that he is very functional and has minimal opportunity for improving his knee function with a total knee replacement. He is a poor candidate for TKR surgery. Conclusions. The patient-specific SDM tool for TKR surgery can distinguish between excellent and poor surgical candidates when both patients meet radiographic criteria for surgery. The pre-operative Oxford Knee Score assesses knee function and/or disability. Patients with relatively high OKSs are less likely to achieve clinically significant improvements after total knee replacement surgery