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The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 3 | Pages 397 - 402
1 Apr 2001
Freedman KB Back S Bernstein J

We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (β < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number. Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 282 - 282
1 May 2009
Hettinga D
Full Access

Purpose and Background: Reliable and valid RCTs are essential in guiding clinical practice, but shortcomings in methodological quality have been reported in RCTs on LBP. The aim of this paper was to use the results of a systematic review on exercise or manual therapies for persistent LBP to evaluate the effect of methodological quality, sample size and statistical rigour on the outcomes of these trials. Methods and Results: The systematic review included 41 RCTs on exercise or manual therapies (i.e. manipulation, mobilisation and/or massage) for persistent (> 6 weeks) non-specific LBP. Quality of the RCTs was assessed using an adapted 10-point Van Tulder scale. Sample size was defined as the number of subjects in the intervention group. Adequate statistical testing was defined as analyses that compared the change in pain or function achieved by the intervention group with the change in the same parameter achieved by the control or alternative group. The results showed that the RCTs with smaller sample sizes or RCTs of lower methodological quality more often reported larger differences in effectiveness than RCTs of higher methodological quality or larger sample sizes. Furthermore, small differences in effectiveness reported by smaller RCTs were often not statistically significant, while larger trials showed that such differences actually were statistically significant. Conclusion: Low methodological quality and small sample size has resulted in misinterpretation of RCTs. Small or low quality RCTs overestimated differences in effectiveness or failed to detect smaller but statistically significant differences. Future RCTs and systematic reviews should address these shortcomings in order to provide reliable guidance for clinical practice


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 8 | Pages 1210 - 1210
1 Nov 2001
PARKER M


Bone & Joint Research
Vol. 3, Issue 11 | Pages 317 - 320
1 Nov 2014
Basso T Klaksvik J Foss OA

Objective. In ex vivo hip fracture studies femoral pairs are split to create two comparable test groups. When more than two groups are required, or if paired femurs cannot be obtained, group allocation according to bone mineral density (BMD) is sometimes performed. In this statistical experiment we explore how this affects experimental results and sample size considerations. Methods. In a hip fracture experiment, nine pairs of human cadaver femurs were tested in a paired study design. The femurs were then re-matched according to BMD, creating two new test groups. Intra-pair variance and paired correlations in fixation stability were calculated. A hypothetical power analysis was then performed to explore the required sample size for the two types of group allocation. . Results. The standard deviation (. sd. ) of the mean paired difference in fixation stability increased from 2 mm in donor pairs to 5 mm in BMD-matched pairs. Intra-pair correlation was 0.953 (Pearson’s r) in donor pairs and non-significant at -0.134 (Pearson’s r) in BMD-matched pairs. Required sample size to achieve a statistical power of 0.8 increased from ten pairs using donor pairs to 54 pairs using BMD-matched pairs. Conclusion. BMD cannot be used to create comparable test groups unless sample size is increased substantially and paired statistics are no longer valid. Cite this article: Bone Joint Res 2014;3:317–20


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1148 - 1155
1 Oct 2022
Watts AC Hamoodi Z McDaid C Hewitt C

Aims. Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research. Methods. A scoping review was undertaken adhering to the Joanna Briggs Institute guidelines using Medline, Embase, CENTRAL, and trial registries, limited to studies published between 1 January 1990 and 7 February 2021. Endnote software was used for screening and selection, and included randomized trials, non-randomized controlled trials, prospective and retrospective cohort studies, case-control studies, analytical cross-sectional studies, and case series of ten or more patients reporting the clinical outcomes of elbow arthroplasty. The results are presented as the number of types of studies, sample size, length of follow-up, clinical outcome domains and instruments used, sources of funding, and a narrative review. Results. A total of 362 studies met the inclusion criteria. Most were of total elbow arthroplasty (246; 68%), followed by radial head arthroplasty (100; 28%), distal humeral hemiarthroplasty (11; 3%), and radiocapitellar arthroplasty (5; 1%). Most were retrospective (326; 90%) and observational (315; 87%). The median sample size for all types of implant across all studies was 36 (interquartile range (IQR) 21 to 75). The median length of follow-up for all studies was 56 months (IQR 36 to 81). A total of 583 unique outcome descriptors were used and were categorized into 18 domains. A total of 105 instruments were used to measure 39 outcomes. Conclusion. We found that most of the literature dealing with elbow arthroplasty consists of retrospective observational studies with small sample sizes and short follow-up. Many outcomes have been used with many different instruments for their measurement, indicating a need to define a core set of outcomes and instruments for future research in this area. Cite this article: Bone Joint J 2022;104-B(10):1148–1155


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims. To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration. Methods. We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map. Results. After screening of 5,660 articles, we included 166 studies reporting prognostic factors for outcomes after rTKA, with a median sample size of 319 patients (30 to 303,867). Overall, 50% of the studies reported prospectively collected data, and 61% of the studies were performed in a single centre. In some studies, multiple associations were reported; 180 different prognostic factors were reported in these studies. The three most frequently studied prognostic factors were reason for revision (213 times), sex (125 times), and BMI (117 times). Studies focusing on functional scores and patient-reported outcome measures as prognostic factor for the outcome after surgery were limited (n = 42). The studies reported 154 different outcomes. The most commonly reported outcomes after rTKA were: re-revision (155 times), readmission (88 times), and reinfection (85 times). Only five studies included costs as outcome. Conclusion. Outcomes and prognostic factors that are routinely registered as part of clinical practice (e.g. BMI, sex, complications) or in (inter)national registries are studied frequently. Studies on prognostic factors, such as functional and sociodemographic status, and outcomes as healthcare costs, cognitive and mental function, and psychosocial impact are scarce, while they have been shown to be important for patients with osteoarthritis. Cite this article: Bone Jt Open 2023;4(5):338–356


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 898 - 901
1 May 2021
Axelrod D Trask K Buckley RE Johal H

Aims. This study reviews the past 30 years of research from the Canadian Orthopedic Trauma Society (COTS), to identify predictive factors that delay or accelerate the course of randomized controlled trials in orthopaedic trauma. Methods. We conducted a methodological review of all papers published through the Canadian Orthopaedic Trauma Society or its affiliates. Data abstracted included: year of publication; journal of publication; study type; number of study sites; sample size; and achievement of sample size goals. Information about the study timelines was also collected, including: the date of study proposal to COTS; date recruitment began; date recruitment ended; and date of publication. Results. In total, 22 studies have been published through the COTS working group, 13 of which are randomized controlled trials (RCTs). In total, 1,423 individual patients have been involved in COTS studies, a mean of 110 patients per trial (22 to 424). Each study was conducted across a mean of approximately six centres (1 to 11) and took nearly ten years (mean 119.9 months (59 to 188)) from presentation of concept to publication. The mean length of enrolment was 63 months (26 to 113) and the mean time from cessation of enrolment to publication 51 months (19 to 78). Regardless of sample size, the only factor associated with a decreased length of enrolment was a higher number of clinical sites (p = 0.041). Neither study sample size nor length of enrolment were associated with total time to publication. Conclusion. Over the last three decades, COTS has developed a multinational strategy to produce high-quality evidence in the field of orthopaedic trauma through 13 multicentre RCTs. Future efficiencies can be realized by recruitment of more clinical sites, improving connectivity between the sites, and the promotion of national streamlined ethics processes. Cite this article: Bone Joint J 2021;103-B(5):898–901


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 57 - 57
2 May 2024
Martin A Alsousou J Chou D Costa M Carrothers A
Full Access

Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients. This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures. Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8. This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options


Bone & Joint Research
Vol. 11, Issue 6 | Pages 398 - 408
22 Jun 2022
Xu T Zeng Y Yang X Liu G Lv T Yang H Jiang F Chen Y

Aims. We aimed to evaluate the utility of . 68. Ga-citrate positron emission tomography (PET)/CT in the differentiation of periprosthetic joint infection (PJI) and aseptic loosening (AL), and compare it with . 99m. Tc-methylene bisphosphonates (. 99m. Tc-MDP) bone scan. Methods. We studied 39 patients with suspected PJI or AL. These patients underwent . 68. Ga-citrate PET/CT, . 99m. Tc-MDP three-phase bone scan and single-photon emission CT (SPECT)/CT. PET/CT was performed at ten minutes and 60 minutes after injection, respectively. Images were evaluated by three nuclear medicine doctors based on: 1) visual analysis of the three methods based on tracer uptake model, and PET images attenuation-corrected with CT and those not attenuation-corrected with CT were analyzed, respectively; and 2) semi-quantitative analysis of PET/CT: maximum standardized uptake value (SUVmax) of lesions, SUVmax of the lesion/SUVmean of the normal bone, and SUVmax of the lesion/SUVmean of the normal muscle. The final diagnosis was based on the clinical and intraoperative findings, and histopathological and microbiological examinations. Results. Overall, 23 and 16 patients were diagnosed with PJI and AL, respectively. The sensitivity and specificity of three-phase bone scan and SPECT/CT were 100% and 62.5%, 82.6%, and 100%, respectively. Attenuation correction (AC) at 60 minutes and non-AC at 60 minutes of PET/CT had the same highest sensitivity and specificity (91.3% and 100%), and AC at 60 minutes combined with SPECT/CT could improve the diagnostic efficiency (sensitivity = 95.7%). Diagnostic efficacy of the SUVmax was low (area under the curve (AUC) of ten minutes and 60 minutes was 0.814 and 0.806, respectively), and SUVmax of the lesion/SUVmean of the normal bone at 60 minutes was the best semi-quantitative parameter (AUC = 0.969). Conclusion. 68. Ga-citrate showed the potential to differentiate PJI from AL, and visual analysis based on uptake pattern of tracer was reliable. The visual analysis method of AC at 60 minutes, combined with . 99m. Tc-MDP SPECT/CT, could improve the sensitivity from 91.3% to 95.7%. In addition, a major limitation of our study was that it had a limited sample size, and more detailed studies with a larger sample size are warranted. Cite this article: Bone Joint Res 2022;11(6):398–408


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 39 - 39
17 Nov 2023
FARHAN-ALANIE M Gallacher D Kozdryk J Craig P Griffin J Mason J Wall P Wilkinson M Metcalfe A Foguet P
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Abstract. Introduction. Component mal-positioning in total hip replacement (THR) and total knee replacement (TKR) can increase the risk of revision for various reasons. Compared to conventional surgery, relatively improved accuracy of implant positioning can be achieved using computer assisted technologies including navigation, patient-specific jigs, and robotic systems. However, it is not known whether application of these technologies has improved prosthesis survival in the real-world. This study aimed to compare risk of revision for all-causes following primary THR and TKR, and revision for dislocation following primary THR performed using computer assisted technologies compared to conventional technique. Methods. We performed an observational study using National Joint Registry data. All adult patients undergoing primary THR and TKR for osteoarthritis between 01/04/2003 to 31/12/2020 were eligible. Patients who received metal-on-metal bearing THR were excluded. We generated propensity score weights, using Sturmer weight trimming, based on: age, gender, ASA grade, side, operation funding, year of surgery, approach, and fixation. Specific additional variables included position and bearing for THR and patellar resurfacing for TKR. For THR, effective sample sizes and duration of follow up for conventional versus computer-guided and robotic-assisted analyses were 9,379 and 10,600 procedures, and approximately 18 and 4 years, respectively. For TKR, effective sample sizes and durations of follow up for conventional versus computer-guided, patient-specific jigs, and robotic-assisted groups were 92,579 procedures over 18 years, 11,665 procedures over 8 years, and 644 procedures over 3 years, respectively. Outcomes were assessed using Kaplan-Meier analysis and expressed using hazard ratios (HR) and 95% confidence intervals (CI). Results. For THR, analysis comparing computer-guided versus conventional technique demonstrated HR of 0.771 (95%CI 0.573–1.036) p=0.085, and 0.594 (95%CI 0.297–1.190) p=0.142, for revision for all-causes and dislocation, respectively. When comparing robotic-assisted versus conventional technique, HR for revision for all-causes was 0.480 (95%CI 0.067 –3.452) p=0.466. For TKR, compared to conventional surgery, HR for all-cause revision for procedures performed using computer guidance and patient-specific jigs were 0.967 (95% CI 0.888–1.052) p=0.430, and 0.937 (95% CI 0.708–1.241) p=0.65, respectively. HR for analysis comparing robotic-assisted versus conventional technique was 2.0940 (0.2423, 18.0995) p = 0.50. Conclusions. This is the largest study investigating this topic utilising propensity score analysis methods. We did not find a statistically significant difference in revision for all-causes and dislocation although these analyses are underpowered to detect smaller differences in effect size between groups. Additional comparison for revision for dislocation between robotic-assisted versus conventionally performed THR was not performed as this is a subset of revision for all-causes and wide confidence intervals were already observed for that analysis. It is also important to mention this NJR analysis study is of an observational study design which has inherent limitations. Nonetheless, this is the most feasible study design to answer this research question requiring use of a large data set due to revision being a rare outcome. 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


Abstract. Design. A pragmatic, multicentre, parallel-group, randomised controlled trial to determine whether the intervention is superior to comparator. Setting. 20 NHS Hospitals. Population. NHS patients <60 years with moderate-severe symptomatic knee OA localised to the medial compartment in whom surgical intervention is indicated. Intervention. Surgery with medial opening wedge high tibial osteotomy (HTO) followed by standard postoperative rehabilitation based on local pathways. Comparator. Tailored non-surgical intervention delivered within an NHS physiotherapy department delivered over 6-contact sessions within a period of 4 months. Outcomes. Primary outcome - 24-month Knee Injury and Osteoarthritis Outcome Score (KOOS); Secondary outcomes - OKS, FJS-12, EQ-5D-3L, Pittsburgh Sleep Problem Scale, Return to Work, secondary surgical interventions and complications at 12 and 24 months following randomisation. Health economic evaluation - 24-month within trial analysis, and a decision analytic simulation model to account for the impacts of future knee replacements (and associated revisions), and their timing relative to retirement and employment potential. Process evaluation – to explore trial eligibility, recruitment and retention rates, acceptability of intervention implementation and patient experience of taking part/contextual factors that influence this. Follow up. 12 months and 24 months post-randomisation. Sample size. 224 patients; (90% power, 2-sided p=0.05, equivalent to a sample size of 97 per group). Allowing for 15% loss to follow up, 112 patients will be recruited to each arm of the trial. Project timelines. Start date 1 August 2022, total project duration 60 months including a 9-month, 5-site internal pilot, with a recruitment rate of 0.7 patients/site/month


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. Results. Between December 2017 and December 2019, 60 patients were recruited (median age 77.4 years, range 63.3 to 88.5) (39/21 M/F ratio). At final nine-month follow-up, 4/60 (7%) had withdrawn, 4/60 (7%) had died, and one had been lost to follow-up; a 98% response rate (50/51) was achieved for the EQ-5D questionnaire. Four deaths were recorded during the three-year trial period: three in the non-surgical treatment group and one in the fix-and-replace group. Conclusion. This study has shown a full-scale RCT to be feasible, but will need international recruitment. The Acetabular Fractures in older patients Intervention Trial (AceFIT) has informed the design of a multinational RCT sample size of 1,474 or 1,974 patients for a minimal clinically important difference of 0.06 on EQ-5D, with a power of 0.8 or 0.9, and loss to follow-up of 20%. This observed patient cohort comprises a medically complex group requiring multidisciplinary care; surgeon, anaesthetist, and ortho-geriatrician input is needed to optimize recovery and rehabilitation. Cite this article: Bone Joint J 2024;106-B(4):401–411


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). Discussion. The results of this study will help guide treatment of dorsally displaced distal radial fractures in the elderly and assess whether surgery offers functional benefit to patients. This is an important finding, as the number of elderly distal radial fractures is estimated to increase in the future due to the ageing population. Evidence-based management strategies are therefore required to ensure the best outcome for the patient and to optimize the use of increasingly scarce healthcare resources. Cite this article: Bone Jt Open 2024;5(10):920–928


Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579


Bone & Joint Research
Vol. 13, Issue 10 | Pages 535 - 545
2 Oct 2024
Zou C Guo W Mu W Wahafu T Li Y Hua L Xu B Cao L

Aims. We aimed to determine the concentrations of synovial vancomycin and meropenem in patients treated by single-stage revision combined with intra-articular infusion following periprosthetic joint infection (PJI), thereby validating this drug delivery approach. Methods. We included 14 patients with PJI as noted in their medical records between November 2021 and August 2022, comprising eight hip and seven knee joint infections, with one patient experiencing bilateral knee infections. The patients underwent single-stage revision surgery, followed by intra-articular infusion of vancomycin and meropenem (50,000 µg/ml). Synovial fluid samples were collected to assess antibiotic concentrations using high-performance liquid chromatography. Results. The peak concentrations of vancomycin and meropenem in the joint cavity were observed at one hour post-injection, with mean values of 14,933.9 µg/ml (SD 10,176.3) and 5,819.1 µg/ml (SD 6,029.8), respectively. The trough concentrations at 24 hours were 5,495.0 µg/ml (SD 2,360.5) for vancomycin and 186.4 µg/ml (SD 254.3) for meropenem. The half-life of vancomycin was 6 hours, while that of meropenem ranged between 2 and 3.5 hours. No significant adverse events related to the antibiotic administration were observed. Conclusion. This method can achieve sustained high antibiotic concentrations within the joint space, exceeding the reported minimum biofilm eradication concentration. Our study highlights the remarkable effectiveness of intra-articular antibiotic infusion in delivering high intra-articular concentrations of antibiotics. The method provided sustained high antibiotic concentrations within the joint cavity, and no severe side-effects were observed. These findings offer evidence to improve clinical treatment strategies. However, further validation is required through studies with larger sample sizes and higher levels of evidence. Cite this article: Bone Joint Res 2024;13(10):535–545


Bone & Joint Open
Vol. 4, Issue 3 | Pages 182 - 187
14 Mar 2023
Sheridan GA Hanlon M Welch-Phillips A Spratt K Hagan R O'Byrne JM Kenny PJ Kurmis AP Masri BA Garbuz DS Hurson CJ

Aims. Hip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings. Methods. A matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing 'cases' were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size. Results. Using a previously-reported ALVAL classification, the majority of pseudotumour-positive caseswere found to have intermediate-grade group 2 (n = 10; 63%) or group 3 (n = 4; 25%) histological findings. Two further patients (13%) had high-grade group 4 lesions. HLA-DQB1*05:03:01 (p = 0.0676) and HLA-DRB1*14:54:01 (p = 0.0676) alleles were significantly associated with a higher risk of pseudotumour formation, while HLA-DQA1*03:01:01 (p = 0.0240), HLA-DRB1*04:04:01 (p = 0.0453), HLA-C*01:02:01 (p = 0.0453), and HLA-B*27:05:02 (p = 0.0855) were noted to confer risk reduction. Conclusion. These findings confirm the association between specific HLA genotypes and the risk of pseudotumour development around MoM hip resurfacings. Specifically, the two ‘at risk’ alleles (DQB1*05:03:01 and DRB1*14:54:01) may hold clinical value in preoperative screening and prospective surgical decision-making. Cite this article: Bone Jt Open 2023;4(3):182–187


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 174 - 181
1 Feb 2024
Mandalia KP Brodeur PG Li LT Ives K Cruz Jr. AI Shah SS

Aims. The aim of this study was to characterize the influence of social deprivation on the rate of complications, readmissions, and revisions following primary total shoulder arthroplasty (TSA), using the Social Deprivation Index (SDI). The SDI is a composite measurement, in percentages, of seven demographic characteristics: living in poverty, with < 12 years of education, single-parent households, living in rented or overcrowded housing, households without a car, and unemployed adults aged < 65 years. Methods. Patients aged ≥ 40 years, who underwent primary TSA between 2011 and 2017, were identified using International Classification of Diseases (ICD)-9 Clinical Modification and ICD-10 procedure codes for TSA in the New York Statewide Planning and Research Cooperative System database. Readmission, reoperation, and other complications were analyzed using multivariable Cox proportional hazards regression controlling for SDI, age, ethnicity, insurance status, and Charlson Comorbidity Index. Results. A total of 17,698 patients with a mean age of 69 years (SD 9.6), of whom 57.7% were female, underwent TSA during this time and 4,020 (22.7%) had at least one complication. A total of 8,113 patients (45.8%) had at least one comorbidity, and the median SDI in those who developed complications 12 months postoperatively was significantly greater than in those without a complication (33 vs 38; p < 0.001). Patients from areas with higher deprivation had increased one-, three-, and 12-month rates of readmission, dislocation, humeral fracture, urinary tract infection, deep vein thrombosis, and wound complications, as well as a higher three-month rate of pulmonary embolism (all p < 0.05). Conclusion. Beyond medical complications, we found that patients with increased social deprivation had higher rates of humeral fracture and dislocation following primary TSA. The large sample size of this study, and the outcomes that were measured, add to the literature greatly in comparison with other large database studies involving TSA. These findings allow orthopaedic surgeons practising in under-served or low-volume areas to identify patients who may be at greater risk of developing complications. Cite this article: Bone Joint J 2024;106-B(2):174–181


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 41 - 41
1 Dec 2021
Brachimi E Rodger C Brown M Jamal B
Full Access

Abstract. Objectives. Currently, the golden standard for the management of ankle fractures is open reduction and internal fixation (ORIF), a procedure which preserves joint anatomy and function. However, ORIF is associated with high risk of infection, especially in the elderly population, who tend to suffer from osteoporosis and vascular disease. Studies recommend hindfoot nailing (HFN) as a safe and efficient management alternative for this demographic. Unlike ORIF, HFN allows immediate weight-bearing, which has been linked to a lower rate of complications. This study aims to evaluate the outcomes of hindfoot nailing in ankle fractures using a case series of 43 patients. Methods. This is a retrospective study with a sample size of 43 patients, that have a mean age of 77.3 years and several medical conditions. These patients experienced ankle fractures that were treated with HFN. Data collected included injury patterns, operative complications, rate of radiological union, comorbidities and changes in mobility and housing before and after surgery. Results. Before their fracture, 62.8% of patients mobilised using a walking stick or a wheeled frame. Following surgery, 52.4% experienced decreased level of mobility. 50% of patients achieved radiological union at the time of data analysis, whereas 52.4% of patients reported a post-operative complication, most commonly soft tissue or bone infection. Conclusions. Our study has a large sample size compared to previous research. The follow-up period varies depending on patient attendance to follow-up clinical appointments. Our patient cohort exhibits significantly lower rates of radiological union, higher incidence of complications and poor post-operative functional outcomes associated with HFN. These data contradict previous studies suggesting HFN for the surgical management of ankle fractures in the elderly and frail population and demonstrate that a more thorough evaluation of HFN is needed


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 872 - 879
1 Aug 2023
Ogawa T Onuma R Kristensen MT Yoshii T Fujiwara T Fushimi K Okawa A Jinno T

Aims. The aim of this study was to investigate the association between additional rehabilitation at the weekend, and in-hospital mortality and complications in patients with hip fracture who underwent surgery. Methods. A retrospective cohort study was conducted in Japan using a nationwide multicentre database from April 2010 to March 2018, including 572,181 patients who had received hip fracture surgery. Propensity score matching was performed to compare patients who received additional weekend rehabilitation at the weekend in addition to rehabilitation on weekdays after the surgery (plus-weekends group), as well as those who did not receive additional rehabilitation at the weekend but did receive weekday rehabilitation (weekdays-only group). After the propensity score matching of 259,168 cases, in-hospital mortality as the primary outcome and systemic and surgical complications as the secondary outcomes were compared between the two groups. Results. The plus-weekends group was significantly associated with lower in-hospital mortality rates compared with the weekdays-only group (hazard ratio 0.86; 95% confidence interval 0.8 to 0.92; p < 0.001). Systemic complications such as acute coronary syndrome, heart failure, renal failure, and sepsis were significantly lower in the plus-weekends group, whereas urinary tract infection (UTI) and surgical complications such as surgical site infection and haematoma were significantly higher in the plus-weekends group. Conclusion. Additional weekend rehabilitation was significantly associated with lower in-hospital mortality, as well as acute coronary syndrome, heart failure, renal failure, and sepsis, but was also significantly associated with a higher risk of UTI and surgical complications. This result can facilitate the effective use of the limited rehabilitation resources at the weekend and improve the clinical awareness of specific complications. To establish more robust causal associations between additional rehabilitation over the weekend and clinical outcomes, further prospective studies or randomized controlled trials with larger sample sizes are warranted. Cite this article: Bone Joint J 2023;105-B(8):872–879


Bone & Joint Research
Vol. 12, Issue 9 | Pages 546 - 558
12 Sep 2023
Shen J Wei Z Wang S Wang X Lin W Liu L Wang G

Aims. This study aimed to evaluate the effectiveness of the induced membrane technique for treating infected bone defects, and to explore the factors that might affect patient outcomes. Methods. A comprehensive search was performed in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases between 1 January 2000 and 31 October 2021. Studies with a minimum sample size of five patients with infected bone defects treated with the induced membrane technique were included. Factors associated with nonunion, infection recurrence, and additional procedures were identified using logistic regression analysis on individual patient data. Results. After the screening, 44 studies were included with 1,079 patients and 1,083 segments of infected bone defects treated with the induced membrane technique. The mean defect size was 6.8 cm (0.5 to 30). After the index second stage procedure, 85% (797/942) of segments achieved union, and 92% (999/1,083) of segments achieved final healing. The multivariate analysis with data from 296 patients suggested that older age was associated with higher nonunion risk. Patients with external fixation in the second stage had a significantly higher risk of developing nonunion, increasing the need for additional procedures. The autografts harvested from the femur reamer-irrigator-aspirator increased nonunion, infection recurrence, and additional procedure rates. Conclusion. The induced membrane technique is an effective technique for treating infected bone defects. Internal fixation during the second stage might effectively promote bone healing and reduce additional procedures without increasing infection recurrence. Future studies should standardize individual patient data prospectively to facilitate research on the affected patient outcomes. Cite this article: Bone Joint Res 2023;12(9):546–558