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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 59 - 59
1 Dec 2021
Vemulapalli KV Kumar KHS Khanduja V
Full Access

Abstract

Purpose

Clinical registries are an important aspect of orthopaedic research in assessing the outcomes of surgical intervention and track medical devices. This study aimed to explore the research methodology available to account for patients lost to follow-up (LTFU) specifically in studies related to arthroscopic intervention and whether the rates of patient LTFU are within the acceptable margins for survey studies.

Methods

A scoping review, where a literature search for studies from nine arthroscopy registries, was performed on EMBASE, MEDLINE, and the annual reports of each registry. Inclusion criteria included studies with information on patient-reported outcome measures and being based on nine national registries identified. Exclusion criteria included review articles, conference abstracts, studies not based on registry data, and studies from regional, claims-based, or multi-centre registries. Studies were then divided into categories based on method of LTFU analysis used.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 911 - 919
21 Oct 2024
Clement N MacDonald DJ Hamilton DF Gaston P

Aims. The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with loss to follow-up and mortality risk. Methods. Long-term follow-up of a randomized controlled trial was undertaken. A total of 212 patients were allocated a Triathlon or a Kinemax TKA. Patients were assessed preoperatively, and one, three, eight, and 12 years postoperatively using the Oxford Knee Score (OKS). Reasons for patient lost to follow-up, mortality, and revision were recorded. Results. A total of 94 patients completed 12-year functional follow-up (62 females, mean age 66 years (43 to 82) at index surgery). There was a clinically significantly greater improvement in the OKS at one year (mean difference (MD) 3.0 (95% CI 0.4 to 5.7); p = 0.027) and three years (MD 4.7 (95% CI 1.9 to 7.5); p = 0.001) for the Triathlon group, but no differences were observed at eight (p = 0.331) or 12 years’ (p = 0.181) follow-up. When assessing the OKS in the patients surviving to 12 years, the Triathlon group had a clinically significantly greater improvement in the OKS (marginal mean 3.8 (95% CI 0.2 to 7.4); p = 0.040). Loss to functional follow-up (53%, n = 109/204) was independently associated with older age (p = 0.001). Patient mortality was the major reason (56.4%, n = 62/110) for loss to follow-up. Older age (p < 0.001) and worse preoperative OKS (p = 0.043) were independently associated with increased mortality risk. An age at time of surgery of ≥ 72 years was 75% sensitive and 74% specific for predicting mortality with an area under the curve of 78.1% (95% CI 70.9 to 85.3; p < 0.001). Conclusion. The Triathlon TKA was associated with clinically meaningful greater improvement in knee-specific outcome when compared to the Kinemax TKA. Loss to follow-up at 12 years was a limitation, and studies planning longer-term functional assessment could limit their cohort to patients aged under 72 years. Cite this article: Bone Jt Open 2024;5(10):911–919


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024. Cite this article: Bone Jt Open 2024;5(4):343–349


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 400 - 411
15 Mar 2023
Hosman AJF Barbagallo G van Middendorp JJ

Aims. The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Methods. Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. Results. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Conclusion. Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research. Cite this article: Bone Joint J 2023;105-B(4):400–411


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 57 - 57
1 Dec 2022
Gazendam A Ekhtiari S Wood T Petruccelli D Tushinski D Winemaker MJ de Beer J
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The Accolade®TMZF is a taper-wedge cementless metaphyseal coated femoral stem widely utilized from 2002-2012. In recent years, there have been reports of early catastrophic failure of this implant. Establishing a deeper understanding of the rate and causes of revision in patients who developed aseptic failure in stems with documented concerns about high failure rates is critical. Understanding any potential patient or implant factors which are risk factors for failure is important to inform both clinicians and patients. We propose a study to establish the long-term survival of this stem and analyze patients who underwent aseptic revision to understand the causes and risk factors for failure. A retrospective review was undertaken of all patients who received a primary total hip arthroplasty with an Accolade® TMZF stem at a high-volume arthroplasty center. The causes and timing of revision surgery were documented and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to minimize loss to follow-up. Survivorship analysis was performed with use of the Kaplan-Meier curves to determine the overall and aseptic survival rates at final follow-up. Patient and implant factors commonly associated with aseptic failure were extracted and Cox proportional hazards model was used. A consecutive series of 2609 unilateral primary THA patients implanted with an Accolade®TMZF femoral hip stem were included. Mean time from primary surgery was 12.4 years (range 22 days to 19.5 years). Cumulative survival was 96.1% ± 0.2 at final follow-up. One hundred and seven patients underwent revision surgery with aseptic loosening of the femoral component was the most common cause of aseptic failure in this cohort (33/2609, 1.3%). Younger age and larger femoral head offset were independent risk factors for aseptic failure. To our knowledge, this is the largest series representing the longest follow-up of this taper-wedge cementless femoral implant. Despite early concerns, the Accolade® TMZF stem has excellent survivorship in this cohort. Trunnionosis as a recognized cause for revision surgery was rare. Younger age and larger femoral head offset were independent risk factors for aseptic failure


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 51 - 51
1 Dec 2022
Gazendam A Bali K Tushinski D Petruccelli D Winemaker MJ de Beer J Wood T
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During total knee arthroplasty (TKA), a tourniquet is often used intraoperatively. There are proposed benefits of tourniquet use including shorter duration of surgery, improved surgical field visualization and increased cement penetration which may improve implant longevity. However, there are also cited side effects that include increased post-operative pain, slowed recovery, skin bruising, neurovascular injury and quadriceps weakness. Randomized controlled trials have demonstrated no differences in implant longevity, however they are limited by short follow-up and small sample sizes. The objective of the current study was to evaluate the rates of revision surgery among patients undergoing cemented TKA with or without an intraoperative tourniquet and to understand the causes and risk factors for failure. A retrospective cohort study was undertaken of all patients who received a primary, cemented TKA at a high-volume arthroplasty centre from January 1999 to December 2010. Patients who underwent surgery without the use of a tourniquet and those who had a tourniquet inflated for the entirety of the case were included. The causes and timing of revision surgery were recorded and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to reduce the loss to follow-up. Survivorship analysis was performed with the use of Kaplan-Meier curves to determine overall survival rates at final follow-up. A Cox proportional hazards model was utilized to evaluate independent predictors of revision surgery. Data from 3939 cases of primary cemented TKA were available for analysis. There were 2276 (58%) cases in which a tourniquet was used for the duration of the surgery and 1663 (42%) cases in which a tourniquet was not utilized. Mean time from the primary TKA was 14.7 years (range 0 days - 22.8 years) when censored by death or revision surgery. There were 150 recorded revisions in the entire cohort, with periprosthetic joint infection (n=50) and aseptic loosening (n=41) being the most common causes for revision. The cumulative survival at final follow-up for the tourniquetless group was 93.8% at final follow-up while the cumulative survival at final follow-up for the tourniquet group was 96.9% at final follow-up. Tourniquetless surgery was an independent predictor for all-cause revision with an HR of 1.53 (95% CI 1.1, 2.1, p=0.011). Younger age and male sex were also independent factors for all cause revision. The results of the current study demonstrate higher all-cause revision rates with tourniquetless surgery in a large cohort of patients undergoing primary cemented TKA. The available literature consists of short-term trials and registry data, which have inherent limitations. Potential causes for increased revision rates in the tourniquetless group include reduced cement penetration, increased intraoperative blood loss and longer surgical. The results of the current study should be taken into consideration, alongside the known risks and benefits of tourniquet use, when considering intraoperative tourniquet use in cemented TKA


Bone & Joint Open
Vol. 3, Issue 5 | Pages 432 - 440
1 May 2022
Craig AD Asmar S Whitaker P Shaw DL Saralaya D

Aims. Tuberculosis (TB) is one of the biggest communicable causes of mortality worldwide. While incidence in the UK has continued to fall since 2011, Bradford retains one of the highest TB rates in the UK. This study aims to examine the local disease burden of musculoskeletal (MSK) TB, by analyzing common presenting factors within the famously diverse population of Bradford. Methods. An observational study was conducted, using data from the Bradford Teaching Hospitals TB database of patients with a formal diagnosis of MSK TB between January 2005 and July 2017. Patient data included demographic data (including nationality/date of entry to the UK), disease focus, microbiology, and management strategies. Disease incidence was calculated using population data from the Office for National Statistics. Poisson confidence intervals were calculated to demonstrate the extent of statistical error. Disease incidence and nationality were also analyzed, and correlation sought, using the chi-squared test. Results. Between January 2005 and July 2017, 109 cases of MSK TB were diagnosed in Bradford. Mean incidence was 1.65 per 100,000 population, per calendar year (SD 0.75). A total of 38 cases required surgical intervention. Low rates of antimicrobial resistance were encountered. A low rate of loss to follow-up was observed (four patients; 3.7%). Overall, 94.5% of patients (n = 103) were successfully treated. 67% of patients (n = 73) reported their country of origin as either India, Pakistan, or Bangladesh. These ethnicities account for around 25% of the local population. Conclusion. Bradford maintains a high prevalence of MSK TB infection relative to national data; the prevalence within the local immigrant population remains grossly disproportionate. Typical associated factors (HIV/hepatitis coinfection, drug resistance), have only modest prevalence in our dataset. However, local socioeconomic factors such as deprivation and poverty appear germane as suggested by global literature. We advocate a high degree of suspicion in treatment of atypical infection in any area with similar population factors to ensure timely diagnosis. Cite this article: Bone Jt Open 2022;3(5):432–440


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 30 - 30
1 Jul 2022
Middleton R Jackson W Alvand A Bottomley N Price A
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Abstract. Background. Since 2012 we have routinely used the cementless Oxford medial unicompartmental knee arthroplasty (mUKA), with microplasty instrumentation, in patients with anteromedial osteoarthritis (AMOA) meeting modern indications. We report the 10-year survival of 1000 mUKA with minimum 4-year follow-up. Methods. National Joint Registry (NJR) surgeon reports were interrogated for each senior author to identify the first 1,000 mUKAs performed for osteoarthritis. A minimum of 4 years follow-up was required. There was no loss to follow-up. The NJR status of each knee was established. For each mUKA revision the indication and mechanism of failure was determined using local patient records. The 10-year implant survival was calculated using life-table analysis. Results. The 1,000 mUKA cohort represented 55% of all primary knee replacements in the period, with an average age of 67.7 years and a 54%/46% male/female split. There were 17 revisions (11 for arthritis progression, 4 infections, 1 dislocation and 1 aseptic loosening). The 10-year survival was 98% (44 at risk in 10th year). One patient sustained a periprosthetic fracture at 3 weeks, treated with buttress plate fixation. Discussion. This is the first detailed series reporting the long-term outcome of the cementless Oxford mUKA implanted using microplasty instrumentation. There was a low failure rate, with only one revision for aseptic loosening. Lateral progression was the commonest cause for revision, with an incidence of 1%. This report provides evidence that the combination of evidence-based indications, well-designed instrumentation and cementless fixation can provide excellent long-term survival for the Oxford mUKA in treating AMOA


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_5 | Pages 32 - 32
1 Apr 2022
French J Filer J Hogan K Fletcher J Mitchell S
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Introduction. Computer hexapod assisted orthopaedic surgery (CHAOS) has previously been shown to provide a predictable and safe method for correcting multiplanar femoral deformity. We report the outcomes of tibial deformity correction using CHAOS, as well as a new cohort of femoral CHAOS procedures. Materials and Methods. Retrospective review of medical records and radiographs for patients who underwent CHAOS for lower limb deformity at our tertiary centre between 2012–2020. Results. There were 70 consecutive cases from 56 patients with no loss to follow-up. Mean age was 40 years (17 to 77); 59% male. There were 48 femoral and 22 tibial procedures. Method of fixation was intramedullary nailing in 47 cases and locking plates in 23. Multiplanar correction was required in 43 cases. The largest correction of rotation was 40 degrees, and angulation was 28 degrees. Mean mechanical axis deviation reduction per procedure was 17.2 mm, maximum 89 mm. Deformity correction was mechanically satisfactory in all patients bar one who was under-corrected, requiring revision. Complications from femoral surgery included one under-correction, two cases of non-union, and one pulmonary embolism. Complications from tibial surgery were one locking plate fatigue failure, one compartment syndrome, one pseudoaneurysm of the anterior tibial artery requiring stenting, and one transient neurapraxia of the common peroneal nerve. There were no deaths. Conclusions. CHAOS can be used for reliable correction of complex deformities of both the femur and tibia. The risk profile appears to differ between femoral and tibial surgeries


Abstract. Objectives. The principle of osteoporotic vertebral compression fracture (OVCF) is fixing instability, providing anterior support, and decompression. Contraindication for vertebroplasty is anterior or posterior wall fracture. The study objectives was to evaluate the efficacy and safety of vertebroplasty with short segmented PMMA cement augmented pedicle screws for OVCF with posterior/anterior wall fracture patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ±0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20±5.90 to 5.30±1.40 postoperative with 5% (3.30± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80±11.9% t0 87.6±13.1% postoperative with 4.5±4.0% loss at final follow-up. One case had cement leakage was found, but the patient is asymptomatic. No implant-related complication was seen. No iatrogenic dural or nerve injury. Conclusions. Treatment with vertebroplasty with cement augmented screw fixation and direct decompression is a great option in treating such a complex situation in fragile age with fragile bones because It provides anterior support with cementing that avoids corpectomy. Short segment fixation has less stress risers at the junctional area


Abstract. Objectives. To evaluate the safety and efficacy of vertebroplasty with short segmented cement augmented pedicle screws fixation for severe osteoporotic vertebral compression fractures (OVCF) with posterior/anterior wall fractured patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ± 0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20 ± 5.90 to 5.30 ± 1.40 postoperative with 5% (3.30 ± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80 ± 11.9% to 87.6 ± 13.1% postoperative with 4.5 ± 4.0% loss at final follow-up. One case had cement leakage was found, but the patient is asymptomatic. No implant-related complication was seen. No iatrogenic dural or nerve injury. Conclusions. Treatment with vertebroplasty with cement augmented screw fixation and direct decompression is a great option in treating such a complex situation in fragile age with fragile bones because. Vertebroplasty is viable option for restoring vertebral anterior column in patients who are considered as contraindications for vertebroplasty, like DGOU-4. It provides anterior support avoiding corpectomy, minimise blood loss and also duration of surgery. Addition of short segment fixation gives adequate support with less stress risers at the junctional area


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 13 - 13
1 Aug 2020
Atrey A Wu J Waddell JP Schemitsch EH Khoshbin A Ward S Bogoch ER
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The purpose of this investigation is to assess the rate of wear the effect once the “bedding in period”/ poly creep had been eliminated. Creep is the visco-elastic deformation that polyethylene exhibits in the first 6–12 weeks. We also assessed the wear pattern of four different bearing couples in total hip arthroplasty (THA): cobalt-chrome (CoCr) versus oxidized zirconium (OxZir) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly-crosslinked polyethylene (XLPE) acetabular liners. This was a randomized control study involving 92 patients undergoing THA. They were randomized to one of four bearing couples: (1) CoCr/UHMWPE (n= 23), (2) OxZir/UHMWPE (n=21), (3) CoCr/XLPE (n=24), (4) OxZir/XLPE (n=24). Patients underwent a posterior approach from one of three surgeons involved in the study. All patients received a porous-coated cementless acetabular shell and a cylindrical proximally coated stem with 28 mm femoral heads. Each patient was reviewed clinically and radiographically at six weeks, three and 12 months, two, five and 10 years after surgery. Standardized anteroposterior and lateral radiographs were taken. All polyethylene wear was measured by an independent blinded reviewer. Linear and volumetric wear rates were measured on radiographs using a validated computer software (Polyware Rev. 5). Creep was defined as the wear at 6 or 12 weeks, depending on if there was a more than 10% difference between both measurements. If a greater than 10% difference occurred than the later period's wear would be defined as creep. 72 hips were included in analysis after exclusion of seven revisions, three deaths and 10 losses to follow-up. The annual linear wear rates (in mm/y) at 10 years were (1) 0.249, (2) 0.250, (3) 0.074 and (4) 0.050. After adjusting for creep these rates become were (1) 0.181, (2) 0.142, (3) 0.040 and (4) 0.023. There is statistical differences between raw and adjusted linear wear rates for all bearing couples. The percentage of the radiographically measured wear at 10 years due to creep is (1) 30% (2) 44%, (3) 58.5% and (4) 51.5% with significant differences in couples with XLPE versus those with UHMWPE. There was no significant correlation between age, gender, cup size, tilt, planar anteversion and the linear or volumetric wear rates. The linear wear rate of both UHMWPE and XLPE are even lower thxdsxzan previously described when creep is factored out. XLPE has again demonstrated far superior linear wear rates at 10 years than UHMWPE. There were no significant differences in wear rate at 10 years between CoCr and OxZir, this may be due to an underpowered study. XLPE exhibits proportionally more creep than UHMWPE within the first 6–12 weeks and accounts for more of the total wear at 10 years as measured radiographically at the end period


Bone & Joint Research
Vol. 8, Issue 10 | Pages 443 - 450
1 Oct 2019
Treacy RBC Holland JP Daniel J Ziaee H McMinn DJW

Objectives. Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated. Methods. This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (. sd. 11; 21 to 82), and 73% of implantations were in female patients. All patients were individually counselled, and a detailed informed consent was obtained prior to operation. Primary resurfacing was carried out in 85 hips, and three cases involved revision of previous MoM HRA. Clinical, radiological, and Oxford Hip Score (OHS) assessments were studied, along with implant survival. Results. There was no loss to follow-up and no actual or impending revision or reoperation. Median OHS increased from 24 (interquartile range (IQR) 20 to 28) preoperatively to 48 (IQR 46 to 48) at the latest follow-up (48 being the best possible score). Radiographs showed one patient had a head-neck junction lucency. No other radiolucency, osteolysis, component migration, or femoral neck thinning was noted. Conclusion. The results in this small consecutive cohort suggest that metal-on-monobloc-XLPE HRA is successful in the short term and merits further investigation as a conservative alternative to the current accepted standard of stemmed THA. However, we would stress that survival data with longer-term follow-up are needed prior to widespread adoption. Cite this article: R. B. C. Treacy, J. P. Holland, J. Daniel, H. Ziaee, D. J. W. McMinn. Preliminary report of clinical experience with metal-on-highly-crosslinked-polyethylene hip resurfacing. Bone Joint Res 2019;8:443–450. DOI: 10.1302/2046-3758.810.BJR-2019-0060.R1


Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Methods

The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 20 - 27
17 Jan 2024
Turgeon TR Vasarhelyi E Howard J Teeter M Righolt CH Gascoyne T Bohm E

Aims

A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis.

Methods

Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 920 - 928
21 Oct 2024
Bell KR Oliver WM White TO Molyneux SG Graham C Clement ND Duckworth AD

Aims

The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups.

Methods

A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178).


Bone & Joint Open
Vol. 5, Issue 7 | Pages 534 - 542
1 Jul 2024
Woods A Howard A Peckham N Rombach I Saleh A Achten J Appelbe D Thamattore P Gwilym SE

Aims

The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy.

Methods

Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.


Bone & Joint Open
Vol. 4, Issue 10 | Pages 808 - 816
24 Oct 2023
Scott CEH Snowden GT Cawley W Bell KR MacDonald DJ Macpherson GJ Yapp LZ Clement ND

Aims

This prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up.

Methods

From 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1052 - 1059
1 Oct 2023
El-Sahoury JAN Kjærgaard K Ovesen O Hofbauer C Overgaard S Ding M

Aims

The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Methods

A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 696 - 704
1 Jul 2024
Barvelink B Reijman M Smidt S Miranda Afonso P Verhaar JAN Colaris JW

Aims

It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting.

Methods

In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure.