Advertisement for orthosearch.org.uk
Results 1 - 39 of 39
Results per page:
The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 801 - 807
1 Jul 2023
Dietrich G Terrier A Favre M Elmers J Stockton L Soppelsa D Cherix S Vauclair F

Aims. Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures. Methods. A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages. Results. The meta-analysis included eight studies, 2,285 observations, and 304 events (nonunion). The random effects model predicted a pooled risk ratio (RR) of 3.68 (95% confidence interval 1.87 to 7.23), which can be considered significant (p = 0.003). It indicates that smoking more than triples the risk of nonunion when a fracture is treated conservatively. Conclusion. Smoking confers a RR of 3.68 for developing a nonunion in patients with a displaced middle third clavicle fracture treated conservatively. We know that most patients with pseudarthrosis will have pain and a poor functional outcome. Therefore, patients should be informed of the significantly higher risks of nonunion and offered smoking cessation efforts and counselling. Moreover, surgery should be considered for any patient who smokes with this type of fracture. Cite this article: Bone Joint J 2023;105-B(7):801–807


Bone & Joint Open
Vol. 3, Issue 4 | Pages 284 - 290
1 Apr 2022
O'Hara NN Carullo J Joshi M Banoub M Claeys KC Sprague S Slobogean GP O'Toole RV

Aims. There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients. Methods. This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin. Results. Of the 782 included patients (mean age 48 years (SD 20); 59% male), 83% (n = 648) received at least one vancomycin dose (cumulative range 1 to 12 g). Overall, 45% of the sample received at least one tobramycin dose (cumulative range 1.2 to 9.6 g). Drug-induced AKI occurred in ten patients (1.2%). No association was found between the cumulative dose of vancomycin and drug-induced AKI (odds ratio (OR) 1.08 (95% credible interval (CrI) 0.52 to 2.14)). Additional doses of tobramycin were associated with a three-fold increase in the adjusted odds of drug-induced AKI (OR 3.66 (95% CrI 1.71 to 8.49)). Specifically, the risk of drug-induced AKI rose substantially after 4.8 g of tobramycin powder (7.5% (95% CrI 1.0 to 35.3)). Conclusion. Cumulative doses of vancomycin were not associated with an increased risk of drug-induced AKI among fracture patients. While the risk of drug-induced AKI remains less than 4% with three or fewer 1.2 g tobramycin doses, the estimated risk increases substantially to 8% after four cumulative doses. Level of evidence: Therapeutic Level III. Cite this article: Bone Jt Open 2022;3(4):284–290


Bone & Joint Open
Vol. 1, Issue 5 | Pages 103 - 114
13 May 2020
James HK Gregory RJH Tennent D Pattison GTR Fisher JD Griffin DR

Aims. The primary aim of the survey was to map the current provision of simulation training within UK and Republic of Ireland (RoI) trauma and orthopaedic (T&O) specialist training programmes to inform future design of a simulation based-curriculum. The secondary aims were to characterize; the types of simulation offered to trainees by stage of training, the sources of funding for simulation, the barriers to providing simulation in training, and to measure current research activity assessing the educational impact of simulation. Methods. The development of the survey was a collaborative effort between the authors and the British Orthopaedic Association Simulation Group. The survey items were embedded in the Performance and Opportunity Dashboard, which annually audits quality in training across several domains on behalf of the Speciality Advisory Committee (SAC). The survey was sent via email to the 30 training programme directors in March 2019. Data were retrieved and analyzed at the Warwick Clinical Trials Unit, UK. Results. Overall, 28 of 30 programme directors completed the survey (93%). 82% of programmes had access to high-fidelity simulation facilities such as cadaveric laboratories. More than half (54%) had access to a non-technical skills simulation training. Less than half (43%) received centralized funding for simulation, a third relied on local funding such as the departmental budget, and there was a heavy reliance on industry sponsorship to partly or wholly fund simulation training (64%). Provision was higher in the mid-stages (ST3-5) compared to late-stages (ST6-8) of training, and was formally timetabled in 68% of prostgrammes. There was no assessment of the impact of simulation training using objective behavioural measures or real-world clinical outcomes. Conclusion. There is currently widespread, but variable, provision of simulation in T&O training in the UK and RoI, which is likely to expand further with the new curriculum. It is important that research activity into the impact of simulation training continues, to develop an evidence base to support investment in facilities and provision


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 104 - 109
20 Feb 2023
Aslam AM Kennedy J Seghol H Khisty N Nicols TA Adie S

Aims

Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients.

Methods

This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively.


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 72 - 81
1 Jan 2023
Stake IK Ræder BW Gregersen MG Molund M Wang J Madsen JE Husebye EE

Aims

The aim of this study was to compare the functional and radiological outcomes and the complication rate after nail and plate fixation of unstable fractures of the ankle in elderly patients.

Methods

In this multicentre study, 120 patients aged ≥ 60 years with an acute unstable AO/OTA type 44-B fracture of the ankle were randomized to fixation with either a nail or a plate and followed for 24 months after surgery. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score. Secondary outcome measures were the Manchester-Oxford Foot Questionnaire, the Olerud and Molander Ankle score, the EuroQol five-dimension questionnaire, a visual analogue score for pain, complications, the quality of reduction of the fracture, nonunion, and the development of osteoarthritis.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims

To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.

Methods

A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 858 - 864
1 Aug 2024
Costa ML Achten J Knight R Campolier M Massa MS

Aims

The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.

Methods

The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.


Bone & Joint Open
Vol. 5, Issue 8 | Pages 621 - 627
1 Aug 2024
Walter N Loew T Hinterberger T Alt V Rupp M

Aims

Fracture-related infections (FRIs) are a devastating complication of fracture management. However, the impact of FRIs on mental health remains understudied. The aim of this study was a longitudinal evaluation of patients’ psychological state, and expectations for recovery comparing patients with recurrent FRI to those with primary FRI.

Methods

A prospective longitudinal study was conducted at a level 1 trauma centre from January 2020 to December 2022. In total, 56 patients treated for FRI were enrolled. The ICD-10 symptom rating (ISR) and an expectation questionnaire were assessed at five timepoints: preoperatively, one month postoperatively, and at three, six, and 12 months.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 602 - 611
21 Aug 2023
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims

To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.

Methods

This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty).


Bone & Joint Open
Vol. 3, Issue 9 | Pages 726 - 732
16 Sep 2022
Hutchison A Bodger O Whelan R Russell ID Man W Williams P Bebbington A

Aims

We introduced a self-care pathway for minimally displaced distal radius fractures, which involved the patient being discharged from a Virtual Fracture Clinic (VFC) without a physical review and being provided with written instructions on how to remove their own cast or splint at home, plus advice on exercises and return to function.

Methods

All patients managed via this protocol between March and October 2020 were contacted by a medical secretary at a minimum of six months post-injury. The patients were asked to complete the Patient-Rated Wrist Evaluation (PRWE), a satisfaction questionnaire, advise if they had required surgery and/or contacted any health professional, and were also asked for any recommendations on how to improve the service. A review with a hand surgeon was organized if required, and a cost analysis was also conducted.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 953 - 962
1 Aug 2022
Johnson NA Fairhurst C Brealey SD Cook E Stirling E Costa M Divall P Hodgson S Rangan A Dias JJ

Aims

There has been an increasing use of early operative fixation for scaphoid fractures, despite uncertain evidence. We conducted a meta-analysis to evaluate up-to-date evidence from randomized controlled trials (RCTs), comparing the effectiveness of the operative and nonoperative treatment of undisplaced and minimally displaced (≤ 2 mm displacement) scaphoid fractures.

Methods

A systematic review of seven databases was performed from the dates of their inception until the end of March 2021 to identify eligible RCTs. Reference lists of the included studies were screened. No language restrictions were applied. The primary outcome was the patient-reported outcome measure of wrist function at 12 months after injury. A meta-analysis was performed for function, pain, range of motion, grip strength, and union. Complications were reported narratively.


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 633 - 639
2 May 2022
Costa ML Achten J Parsons NR

Aims

The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial.

Methods

The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded.


Aims

Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Methods

A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout.


Aims

This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.

Methods

The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1033 - 1039
1 Jun 2021
Coughlin T Norrish AR Scammell BE Matthews PA Nightingale J Ollivere BJ

Aims

Following cast removal for nonoperatively treated distal radius fractures, rehabilitation facilitated by advice leaflet and advice video were compared to a course of face-to-face therapy.

Methods

Adults with an isolated, nonoperatively treated distal radius fracture were included at six weeks post-cast removal. Participants were randomized to delivery of rehabilitation interventions in one of three ways: an advice leaflet; an advice video; or face-to-face therapy session(s). The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at six weeks post intervention and secondary outcome measures included DASH at one year, DASH work subscale, grip strength, and range of motion at six weeks and one year.


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

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.


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.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 746 - 754
1 Apr 2021
Schnetzke M El Barbari J Schüler S Swartman B Keil H Vetter S Gruetzner PA Franke J

Aims

Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation.

Methods

A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days).


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.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 286 - 293
1 Feb 2021
Park CH Yan H Park J

Aims

No randomized comparative study has compared the extensile lateral approach (ELA) and sinus tarsi approach (STA) for Sanders type 2 calcaneal fractures. This randomized comparative study was conducted to confirm whether the STA was prone to fewer wound complications than the ELA.

Methods

Between August 2013 and August 2018, 64 patients with Sanders type 2 calcaneus fractures were randomly assigned to receive surgical treatment by the ELA (32 patients) and STA (32 patients). The primary outcome was development of wound complications. The secondary outcomes were postoperative complications, pain scored of a visual analogue scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) score, 36-item Short Form health survey, operative duration, subtalar joint range of motion (ROM), Böhler’s angle and calcaneal width, and posterior facet reduction.


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 912 - 917
1 Jul 2020
Tahir M Chaudhry EA Zimri FK Ahmed N Shaikh SA Khan S Choudry UK Aziz A Jamali AR

Aims

It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT.

Methods

This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples t-test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 48 - 54
1 Jan 2020
Gwilym S Sansom L Rombach I Dutton SJ Achten J Costa ML

Aims

Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment.

Methods

This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1408 - 1415
1 Nov 2019
Hull PD Chou DTS Lewis S Carrothers AD Queally JM Allison A Barton G Costa ML

Aims

The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients.

Patients and Methods

Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury.


Aims

This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures.

Patients and Methods

This was a pragmatic, multicentre, multisurgeon, two-arm, parallel group, randomized standard-of-care controlled trial. It was embedded within the WHiTE Comprehensive Cohort Study. The sample size was 964 patients. The setting was five National Health Service Trauma Hospitals in England. A total of 964 patients over 60 years of age who required hemiarthroplasty of the hip between February 2015 and March 2016 were included. A standardized measure of health outcome, the EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and at four months following the operation.


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 973 - 983
1 Jul 2018
Schmal H Froberg L S. Larsen M Südkamp NP Pohlemann T Aghayev E Goodwin Burri K

Aims

The best method of treating unstable pelvic fractures that involve the obturator ring is still a matter for debate. This study compared three methods of treatment: nonoperative, isolated posterior fixation and combined anteroposterior stabilization.

Patients and Methods

The study used data from the German Pelvic Trauma Registry and compared patients undergoing conservative management (n = 2394), surgical treatment (n = 1345) and transpubic surgery, including posterior stabilization (n = 730) with isolated posterior osteosynthesis (n = 405) in non-complex Type B and C fractures that only involved the obturator ring anteriorly. Calculated odds ratios were adjusted for potential confounders. Outcome criteria were intraoperative and general short-term complications, the incidence of nerve injuries, and mortality.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture.

Patients and Methods

Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D3 orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity.

Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1526 - 1532
1 Nov 2017
Tarride JE Hopkins RB Blackhouse G Burke N Bhandari M Johal H Guyatt GH Busse JW

Aims

This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial.

Patients and Methods

Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated.


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 686 - 689
1 May 2016
Griffin XL Parsons N McArthur J Achten J Costa ML

Aims

The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur.

Patients and Methods

This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible.


Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

Background

Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes.

Design

This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.


The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 383 - 392
1 Mar 2017
Handoll HH Keding A Corbacho B Brealey SD Hewitt C Rangan A

Aims

The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

Patients and Methods

Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied.


Bone & Joint Research
Vol. 5, Issue 10 | Pages 481 - 489
1 Oct 2016
Handoll HHG Brealey SD Jefferson L Keding A Brooksbank AJ Johnstone AJ Candal-Couto JJ Rangan A

Objectives

Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.

Methods

The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.


Bone & Joint Research
Vol. 4, Issue 12 | Pages 190 - 194
1 Dec 2015
Kleinlugtenbelt YV Hoekstra M Ham SJ Kloen P Haverlag R Simons MP Bhandari M Goslings JC Poolman RW Scholtes VAB

Objectives

Current studies on the additional benefit of using computed tomography (CT) in order to evaluate the surgeons’ agreement on treatment plans for fracture are inconsistent. This inconsistency can be explained by a methodological phenomenon called ‘spectrum bias’, defined as the bias inherent when investigators choose a population lacking therapeutic uncertainty for evaluation. The aim of the study is to determine the influence of spectrum bias on the intra-observer agreement of treatment plans for fractures of the distal radius.

Methods

Four surgeons evaluated 51 patients with displaced fractures of the distal radius at four time points: T1 and T2: conventional radiographs; T3 and T4: radiographs and additional CT scan (radiograph and CT). Choice of treatment plan (operative or non-operative) and therapeutic certainty (five-point scale: very uncertain to very certain) were rated. To determine the influence of spectrum bias, the intra-observer agreement was analysed, using Kappa statistics, for each degree of therapeutic certainty.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1264 - 1270
1 Sep 2015
Karantana A Scammell BE Davis TRC Whynes DK

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. .

There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively.

NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier.

We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture.

Cite this article: Bone Joint J 2015;97-B:1264–70.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 372 - 382
1 Mar 2015
Griffin XL Parsons N Achten J Fernandez M Costa ML

Hip fracture is a global public health problem. The National Hip Fracture Database provides a framework for service evaluation in this group of patients in the United Kingdom, but does not collect patient-reported outcome data and is unable to provide meaningful data about the recovery of quality of life.

We report one-year patient-reported outcomes of a prospective cohort of patients treated at a single major trauma centre in the United Kingdom who sustained a hip fracture between January 2012 and March 2014.

There was an initial marked decline in quality of life from baseline measured using the EuroQol 5 Dimensions score (EQ-5D). It was followed by a significant improvement to 120 days for all patients. Although their quality of life improved during the year after the fracture, it was still significantly lower than before injury irrespective of age group or cognitive impairment (mean reduction EQ-5D 0.22; 95% confidence interval (CI) 0.17 to 0.26). There was strong evidence that quality of life was lower for patients with cognitive impairment. There was a mean reduction in EQ-5D of 0.28 (95% CI 0.22 to 0.35) in patients <  80 years of age. This difference was consistent (and fixed) throughout follow-up. Quality of life does not improve significantly during recovery from hip fracture in patients over 80 years of age (p = 0.928). Secondary measures of function showed similar trends.

Hip fracture marks a step down in the quality of life of a patient: it accounts for approximately 0.22 disability adjusted life years in the first year after fracture. This is equivalent to serious neurological conditions for which extensive funding for research and treatment is made available.

Cite this article: Bone Joint J 2015;97-B:372–82.


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 652 - 657
1 May 2014
Griffin XL Parsons N Achten J Costa ML

We compared a new fixation system, the Targon Femoral Neck (TFN) hip screw, with the current standard treatment of cannulated screw fixation. This was a single-centre, participant-blinded, randomised controlled trial. Patients aged 65 years and over with either a displaced or undisplaced intracapsular fracture of the hip were eligible. The primary outcome was the risk of revision surgery within one year of fixation.

A total of 174 participants were included in the trial. The absolute reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5) in favour of the TFN hip screw (chi-squared test, p = 0.741), which was less than the pre-specified level of minimum clinically important difference. There were no significant differences in any of the secondary outcome measures.

We found no evidence of a clinical difference in the risk of revision surgery between the TFN hip screw and cannulated screw fixation for patients with an intracapsular fracture of the hip.

Cite this article: Bone Joint J 2014;96-B:652–7.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1544 - 1550
1 Nov 2013
Uchiyama S Itsubo T Nakamura K Fujinaga Y Sato N Imaeda T Kadoya M Kato H

This multicentre prospective clinical trial aimed to determine whether early administration of alendronate (ALN) delays fracture healing after surgical treatment of fractures of the distal radius. The study population comprised 80 patients (four men and 76 women) with a mean age of 70 years (52 to 86) with acute fragility fractures of the distal radius requiring open reduction and internal fixation with a volar locking plate and screws. Two groups of 40 patients each were randomly allocated either to receive once weekly oral ALN administration (35 mg) within a few days after surgery and continued for six months, or oral ALN administration delayed until four months after surgery. Postero-anterior and lateral radiographs of the affected wrist were taken monthly for six months after surgery. No differences between groups was observed with regard to gender (p = 1.0), age (p = 0.916), fracture classification (p = 0.274) or bone mineral density measured at the spine (p = 0.714). The radiographs were assessed by three independent assessors. There were no significant differences in the mean time to complete cortical bridging observed between the ALN group (3.5 months (se 0.16)) and the no-ALN group (3.1 months (se 0.15)) (p = 0.068). All the fractures healed in the both groups by the last follow-up. Improvement of the Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, grip strength, wrist range of movement, and tenderness over the fracture site did not differ between the groups over the six-month period. Based on our results, early administration of ALN after surgery for distal radius fracture did not appear to delay fracture healing times either radiologically or clinically.

Cite this article: Bone Joint J 2013;95-B:1544–50.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 1 | Pages 80 - 88
1 Jan 2007
El-Rosasy MA

We have managed 21 patients with a fracture of the tibia complicated by bone and soft-tissue loss as a result of an open fracture in 10, or following debridement of an infected nonunion in 11, by resection of all the devitalised tissues, acute limb shortening to close the defect, application of an external fixator and metaphyseal osteotomy for re-lengthening. The mean bone loss was 4.7 cm (3 to 11). The mean age of the patients was 28.8 years (12 to 54) and the mean follow-up was 34.8 months (24 to 75).

All the fractures united with a well-aligned limb. The mean duration of treatment for the ten grade-III A+B open fractures (according to the Gustilo-Anderson classification) was 5.7 months (4.5 to 8) and for the nonunions, 7.6 months (5.5 to 12.5). Complications included one refracture, one transient palsy of the peroneal nerve and one equinus contracture of 10°.