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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. Results. Seven RCTs were included. There was no significant difference in function between the groups at 12 months (Hedges’ g 0.15 (95% confidence interval -0.02 to 0.32); p = 0.082). The complication rate was higher in the operative group and involved more serious complications. Conclusion. We found no difference in functional outcome at 12 months for fractures of the waist of the scaphoid with ≤ 2 mm displacement treated operatively or nonoperatively. The complication rate was higher with operative treatment. Cite this article: Bone Joint J 2022;104-B(8):953–962


Bone & Joint Open
Vol. 2, Issue 8 | Pages 646 - 654
16 Aug 2021
Martin JR Saunders PE Phillips M Mitchell SM Mckee MD Schemitsch EH Dehghan N

Aims. The aims of this network meta-analysis (NMA) were to examine nonunion rates and functional outcomes following various operative and nonoperative treatments for displaced mid-shaft clavicle fractures. Methods. Initial search strategy incorporated MEDLINE, PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials (RCTs). Four treatment arms were created: nonoperative (NO); intramedullary nailing (IMN); reconstruction plating (RP); and compression/pre-contoured plating (CP). A Bayesian NMA was conducted to compare all treatment options for outcomes of nonunion, malunion, and function using the Disabilities of the Arm Shoulder and Hand (DASH) and Constant-Murley Shoulder Outcome scores. Results. In all, 19 RCTs consisting of 1,783 clavicle fractures were included in the NMA. All surgical options demonstrated a significantly lower odds ratio (OR) of nonunion in comparison to nonoperative management: CP versus NO (OR 0.08; 95% confidence interval (CI) 0.04 to 0.17); IMN versus NO (OR 0.07; 95% CI 0.02 to 0.19); RP versus NO (OR 0.07; 95% CI: 0.01 to 0.24). Compression plating was the only treatment to demonstrate significantly lower DASH scores relative to NO at six weeks (mean difference -10.97; 95% CI -20.69 to 1.47). Conclusion. Surgical fixation demonstrated a lower risk of nonunion compared to nonoperative management. Compression plating resulted in significantly less disability early after surgery compared to nonoperative management. These results demonstrate possible early improved functional outcomes with compression plating compared to nonoperative treatment. Surgical fixation of mid-shaft clavicle fractures with compression plating may result in quicker return to activity by rendering patients less disabled early after surgery. Cite this article: Bone Jt Open 2021;2(8):646–654


Bone & Joint Open
Vol. 2, Issue 7 | Pages 486 - 492
8 Jul 2021
Phelps EE Tutton E Costa M Hing C

Aims. To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results. The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. Conclusion. Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice. Cite this article: Bone Jt Open 2021;2(7):486–492


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


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1119 - 1125
1 Aug 2016
Coughlin TA Ng JWG Rollins KE Forward DP Ollivere BJ

Aims. Flail chest from a blunt injury to the thorax is associated with significant morbidity and mortality. Its management globally is predominantly non-operative; however, there are an increasing number of centres which undertake surgical stabilisation. The aim of this meta-analysis was to compare the efficacy of this approach with that of non-operative management. Patients and Methods. A systematic search of the literature was carried out to identify randomised controlled trials (RCTs) which compared the clinical outcome of patients with a traumatic flail chest treated by surgical stabilisation of any kind with that of non-operative management. Results. Of 1273 papers identified, three RCTs reported the results of 123 patients with a flail chest. Surgical stabilisation was associated with a two thirds reduction in the incidence of pneumonia when compared with non-operative management (risk ratio 0.36, 95% confidence interval (CI) 0.15 to 0.85, p = 0.02). The duration of mechanical ventilation (mean difference -6.30 days, 95% CI -12.16 to -0.43, p = 0.04) and length of stay in an intensive care unit (mean difference -6.46 days, 95% CI 9.73 to -3.19, p = 0.0001) were significantly shorter in the operative group, as was the overall length of stay in hospital (mean difference -11.39, 95% CI -12.39 to -10.38, p < 0.0001). Conclusion. Surgical stabilisation for a traumatic flail chest is associated with significant clinical benefits in this meta-analysis of three relatively small RCTs. Cite this article: Bone Joint J 2016;98-B:1119–25


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_16 | Pages 11 - 11
1 Apr 2013
Hoang-Kim A Beaton D Kulkarni AV Bhandari M Schemitsch E
Full Access

Introduction. There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment. Materials and methods. Using multiple databases inclusive from 1990 to May 2009, we performed a systematic review of all hip fracture observational cohorts and randomized studies (RCTs). Results. We compared the screening and outcome measures in 190 studies: 79 unique RCTs and 111 cohorts were included (kappa, 0.83; 95% CI: 0.79 − 0.87). In RCTs, 24 (30.4%) trials screened for co-morbidities, 19 (24.1%) trials screened for cognitive impairment, and only 14 (17.7%) trials included patients with dementia. In the cohort studies, 27 (24.3%) screened for co-morbidities, 47 (42.3%) screened for cognitive impairment, and only 33 (29.7%) included patients with dementia. In the 7 cohorts that used proxy responders to assess functional outcomes, only one measured health status and two measured utility. Discussion and Conclusion. Studies would be more relevant to surgeons and patients if researchers measured health status and utilized screening methods for dementia to promote better treatment strategies


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.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 236 - 242
22 Mar 2024
Guryel E McEwan J Qureshi AA Robertson A Ahluwalia R

Aims

Ankle fractures are common injuries and the third most common fragility fracture. In all, 40% of ankle fractures in the frail are open and represent a complex clinical scenario, with morbidity and mortality rates similar to hip fracture patients. They have a higher risk of complications, such as wound infections, malunion, hospital-acquired infections, pressure sores, veno-thromboembolic events, and significant sarcopaenia from prolonged bed rest.

Methods

A modified Delphi method was used and a group of experts with a vested interest in best practice were invited from the British Foot and Ankle Society (BOFAS), British Orthopaedic Association (BOA), Orthopaedic Trauma Society (OTS), British Association of Plastic & Reconstructive Surgeons (BAPRAS), British Geriatric Society (BGS), and the British Limb Reconstruction Society (BLRS).


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.


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.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 150 - 156
1 Jan 2022
Leino OK Lehtimäki KK Mäkelä K Äärimaa V Ekman E

Aims

Proximal humeral fractures (PHFs) are common. There is increasing evidence that most of these fractures should be treated conservatively. However, recent studies have shown an increase in use of operative treatment. The aim of this study was to identify the trends in the incidence and methods of treatment of PHFs in Finland.

Methods

The study included all Finnish inhabitants aged ≥ 16 years between 1997 and 2019. All records, including diagnostic codes for PHFs and all surgical procedure codes for these fractures, were identified from two national registers. Data exclusion criteria were implemented in order to identify only acute PHFs, and the operations performed to treat them.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 127 - 133
1 Jan 2022
Viberg B Pedersen AB Kjærsgaard A Lauritsen J Overgaard S

Aims

The aim of this study was to assess the association of mortality and reoperation when comparing cemented and uncemented hemiarthroplasty (HA) in hip fracture patients aged over 65 years.

Methods

This was a population-based cohort study on hip fracture patients using prospectively gathered data from several national registries in Denmark from 2004 to 2015 with up to five years follow-up. The primary outcome was mortality and the secondary outcome was reoperation. Hazard ratios (HRs) for mortality and subdistributional hazard ratios (sHRs) for reoperations are shown with 95% confidence intervals (CIs).


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 729 - 735
1 Jun 2022
Craxford S Marson BA Nightingale J Forward DP Taylor A Ollivere B

Aims

The last decade has seen a marked increase in surgical rib fracture fixation (SRF). The evidence to support this comes largely from retrospective cohorts, and adjusting for the effect of other injuries sustained at the same time is challenging. This study aims to assess the impact of SRF after blunt chest trauma using national prospective registry data, while controlling for other comorbidities and injuries.

Methods

A ten-year extract from the Trauma Audit and Research Network formed the study sample. Patients who underwent SRF were compared with those who received supportive care alone. The analysis was performed first for the entire eligible cohort, and then for patients with a serious (thoracic Abbreviated Injury Scale (AIS) ≥ 3) or minor (thoracic AIS < 3) chest injury without significant polytrauma. Multivariable logistic regression was performed to identify predictors of mortality. Kaplan-Meier estimators and multivariable Cox regression were performed to adjust for the effects of concomitant injuries and other comorbidities. Outcomes assessed were 30-day mortality, length of stay (LoS), and need for tracheostomy.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 134 - 141
1 Jan 2022
Cnudde PHJ Nåtman J Hailer NP Rogmark C

Aims

The aim of this study was to investigate the potentially increased risk of dislocation in patients with neurological disease who sustain a femoral neck fracture, as it is unclear whether they should undergo total hip arthroplasty (THA) or hemiarthroplasty (HA). A secondary aim was to investgate whether dual-mobility components confer a reduced risk of dislocation in these patients.

Methods

We undertook a longitudinal cohort study linking the Swedish Hip Arthroplasty Register with the National Patient Register, including patients with a neurological disease presenting with a femoral neck fracture and treated with HA, a conventional THA (cTHA) with femoral head size of ≤ 32 mm, or a dual-mobility component THA (DMC-THA) between 2005 and 2014. The dislocation rate at one- and three-year revision, reoperation, and mortality rates were recorded. Cox multivariate regression models were fitted to calculate adjusted hazard ratios (HRs).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 480 - 480
1 Sep 2012
Andersen K Christensen A Petersen M Christensen B Pedersen N Soballe K
Full Access

Background. Randomized, controlled trials (RCTs) are generally accepted as the “gold standard” for the provision of the most unbiased measures of the efficacy of interventions but are often criticized for the lack of external validity. We assessed the external validity of a RCT examining the efficacy of local infiltration analgesia (LIA) compared with continuous epidural infusion after total knee arthroplasty (TKA). Methods. During a one-year period, all patients consecutively admitted for elective, unilateral, primary TKA were identified as potential participants. All underwent eligibility screening to determine who were eligible for participation in a randomized controlled trial. We investigated the distribution of preoperative characteristics and postoperative variables among excluded patients, non-consenters, and enrolled and randomized participants. Results. In all 157 patients were identified as potential participants. Only 49 patients (31%) were enrolled and randomized. A significant difference was found in both preoperative characteristics and clinical outcome variables. Non-participants were less healthy and needed more help from the home care service than did participants. Furthermore, they were hospitalized longer. Interpretation. Our findings demonstrate the importance of reporting the results of RCTs in a way that allows clinicians to judge to whom the results can reasonably be applied


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 274 - 282
1 Feb 2022
Grønhaug KML Dybvik E Matre K Östman B Gjertsen J

Aims

The aim of this study was to investigate if there are differences in outcome between sliding hip screws (SHSs) and intramedullary nails (IMNs) with regard to fracture stability.

Methods

We assessed data from 17,341 patients with trochanteric or subtrochanteric fractures treated with SHS or IMN in the Norwegian Hip Fracture Register from 2013 to 2019. Primary outcome measures were reoperations for stable fractures (AO Foundation/Orthopaedic Trauma Association (AO/OTA) type A1) and unstable fractures (AO/OTA type A2, A3, and subtrochanteric fractures). Secondary outcome measures were reoperations for A2, A3, and subtrochanteric fractures individually, one-year mortality, quality of life (EuroQol five-dimension three-level index score), pain (visual analogue scale (VAS)), and satisfaction (VAS) for stable and unstable fractures. Hazard rate ratios (HRRs) for reoperation were calculated using Cox regression analysis with adjustments for age, sex, and American Society of Anesthesiologists score.


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.


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1027 - 1034
1 Dec 2021
Hassellund S Zolic-Karlsson Z Williksen JH Husby T Madsen JE Frihagen F

Aims

The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a cost-effectiveness analysis.

Methods

A cost-utility analysis was performed alongside a randomized controlled trial. A total of 50 patients were randomized to each group. We prospectively collected data on resource use during the first year post-fracture, and estimated costs of initial treatment, further operations, physiotherapy, home nursing, and production loss. Health-related quality of life was based on the Euro-QoL five-dimension, five-level (EQ-5D-5L) utility index, and quality-adjusted life-years (QALYs) were calculated.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1802 - 1808
1 Dec 2021
Bruce J Knight R Parsons N Betteridge R Verdon A Brown J Campolier M Achten J Costa ML

Aims

Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery.

Methods

Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 447 - 447
1 Sep 2012
Kulikov Y Parsons N Griffin D
Full Access

Introduction. There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle. Methods. We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs. Results. 70 consecutive patients (77 calcaneal fractures) were assessed by a panel of 12 Consultant Trauma surgeons from hospitals acros the UK. All patients were eligible for the UK HeFT according to standard eligibility criteria approach. UnIx demonstrated reliable correlation with level of uncertainty and confidence about treatment choice expressed by surgeons. The panel was certain about treatment for 9 (13%) patients. The assesment results were available within 48 hours from a case submission to the panel. Discussion and Conclusion. UnIx is an effective and ethical eligibility assessment tool based on surgeon's opinion. It can be calculated for every patient in Randomised Controlled Trials. This protects patients when there is no controversy about treatment choice. UnIx can potentially increase patient recruitment by including more patients for eligibility assessment and more sceptical surgeons in clinical trials. Patient's perception that his/her condition was assessed by surgical panel may also be important