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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 57 - 57
1 Apr 2017
Aragonés M Hevia E Caballero A Barrios C
Full Access

Background. The controversy concerning the benefits of unisegmental cervical disc arthroplasty (CDA) over anterior cervical discectomy and fusion (ACDF) is still open because some randomised clinical trial (RTC) comparing ACDF with CDA have been highly inconclusive. Most of these studies mixed disc prosthesis with dissimilar kinematic characteristics. To date, a compilation of the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) compared with a single cervical disc arthroplasty (CDA) design, the Bryan disc has partially accomplished. Methods. This is a systematic review of RCTs with level I-II evidence. Only RCTs reporting clinical outcomes were included in this review. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of total 51 studies were entered in the study. RTC's were searched from the earliest available records in 2005 to December 2014. Results. Five studies were Level I, and five were Level II. Out of a total of 1101 patients, 562 patients were randomly assigned into the Bryan arthroplasty group and the remaining 539 patients into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing CDA had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with Bryan CDA had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level were slightly higher in patients with ACDF, showing no statistically significant difference. Conclusions. This review of evidence level I-II RCTs comparing clinical and radiological outcomes of patient undergoing Bryan arthroplasty or ACDF indicated a global superiority of the Bryan disc. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and Bryan arthroplasty. These data suggest that even though the loss of motion has a determinant influence in the development of degenerative changes in ACDF cases, these kinematic factors do not imply a higher rate of symptomatic adjacent segment degeneration requiring surgery. Level of Evidence. Level I


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 386 - 386
1 Jul 2011
Sandhu J Deakin A Munro N
Full Access

The orthopaedic unit at the Golden Jubilee National Hospital consists of eight consultant orthopaedic surgeons who have a varied practice with regard to navigated TKA with some surgeons using navigation for all cases, some for what are deemed difficult cases and others using it rarely or not at all. One mechanical jig-based system and two different navigation systems are in routine use. The results from the two navigated (nav 1 and nav 2) and non-navigated (non-nav) systems were audited and compared with published studies to determine whether the reported results from randomised controlled trials were reproduced in our routine practice. The primary outcome measure was the mechanical femorotibial (MFT) angle as measured by Hip-Knee-Ankle (HKA) radiographs. This is a standard outcome measure that allowed ready comparison with other studies. Demographic data and post-operative MFT angles were collected retrospectively for each patient. The HKA digital radiographs (stored on a Picture Archive and Communication system) were taken six to twelve weeks post-operatively. The MFT angle was measured using a standardised protocol, which used the method of Mose to find the centre of the femoral head, the highest point in the femoral notch as the centre of the knee and the middle of the talus for the centre of the ankle. Repeated measurements were taken to identify intra- and inter-observer error. There were 86 patients in the nav 1 series, 95 in nav 2 and 95 in non-nav. Mean age was nav 1 = 70, nav 2 = 69 and non-nav = 71. Mean BMI was nav 1 = 34, nav 2 = 31.5 and non-nav = 30. Male to female ratio was nav 1 = 51:35, nav 2 = 44:51 and non-nav = 30:65. Intra- and inter- observer comparison showed a maximum difference of 1° for the measurement of MFT angle. For series nav 1 74% of TKAs had a MFT angle in the range ±3°, for series nav 2 this was 85% and for the non-nav series it was 68%. Much of the literature on RCTs for navigation vs. non navigation outcomes in TKA indicates that over 93 % of patients undergoing navigated TKA have a mechanical axis alignment within the ±3° range, with non-navigated techniques having 73–87% within this range [. 1. ,. 2. ]. Our audit shows lower percentages for both navigated and non-navigated techniques. Our results are however similar to those obtained by Chauhan et al. [. 3. ] with 85% and 66% respectively. The lower numbers of patients falling into the ±3° range may be due to our audit covering a number of surgeons and trainees. The nav 1 series had five consultants and six trainees, nav 2 had two consultants and the non-nav series had four consultant and six trainees. It may also relate to the extent of pre-operative deformities, which were not quantified. In conclusion the high levels of TKA coronal alignment within ±3° seen in many RCTs may not be readily reproducible in a general setting


Bone & Joint Research
Vol. 13, Issue 9 | Pages 474 - 484
10 Sep 2024
Liu Y Li X Jiang L Ma J

Aims. Rotator cuff tear (RCT) is the leading cause of shoulder pain, primarily associated with age-related tendon degeneration. This study aimed to elucidate the potential differential gene expressions in tendons across different age groups, and to investigate their roles in tendon degeneration. Methods. Linear regression and differential expression (DE) analyses were performed on two transcriptome profiling datasets of torn supraspinatus tendons to identify age-related genes. Subsequent functional analyses were conducted on these candidate genes to explore their potential roles in tendon ageing. Additionally, a secondary DE analysis was performed on candidate genes by comparing their expressions between lesioned and normal tendons to explore their correlations with RCTs. Results. We identified 49 genes in torn supraspinatus tendons associated with advancing age. Among them, five age-related genes showed DE in lesioned tendons compared to normal tendons. Functional analyses and previous studies have highlighted their specific enrichments in biological functions, such as muscle development (e.g. myosin heavy chain 3 (MYH3)), transcription regulation (e.g. CCAAT enhancer binding brotein delta (CEBPD)), and metal ion homeostasis (e.g. metallothionein 1X (MT1X)). Conclusion. This study uncovered molecular aspects of tendon ageing and their potential links to RCT development, offering insights for targeted interventions. These findings enhance our understanding of the mechanisms of tendon degeneration, allowing potential strategies to be made for reducing the incidence of RCT. Cite this article: Bone Joint Res 2024;13(9):474–484


Bone & Joint Research
Vol. 10, Issue 9 | Pages 591 - 593
7 Sep 2021
Thompson JW Simpson AHRW Haddad FS


Bone & Joint Open
Vol. 2, Issue 9 | Pages 773 - 784
1 Sep 2021
Rex SS Kottam L McDaid C Brealey S Dias J Hewitt CE Keding A Lamb SE Wright K Rangan A

Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. Methods. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. Results. Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. Conclusion. The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773–784


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. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 117 - 117
4 Apr 2023
Du L Yang B Zhong Z Wu K
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The principal of “function priority, early rehabilitation, and return to sports” is now the goal for sports injury rehabilitation. Neuromuscular electrical stimulation for anterior cruciate ligament (ACL) reconstruction is a rising procedure for early rehabilitation. This paper systematically assessed the effects of neuromuscular electrical stimulation on postoperative ACL reconstruction to provide guidance for physiotherapist and patient when designing a suitable rehabilitation protocol. To evaluate the interventional outcomes of neuromuscular electrical stimulation following ACL reconstruction, we searched PubMed, EMbase, the Cochrane Library, Web of Science and CNKI to collect all randomized controlled trials (RCTs) comparing the effects with neuromuscular electrical stimulation and without intervention on rehabilitation after ACL reconstruction up to January 30, 2022. Two investigators independently performed literature screening, data extraction, bias assessment of risk, and used RevMan 5.3 software to conduct a meta-analysis. A total of six RCTs were included, and the results showed that the use of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction significantly improved the International Knee Documentation Committee (IKDC) scores (MD 6.33, 95% CI [-0.43, 12.22]; I2 = 66%; p = 0.040), the Lysholm score (MD 7.94, 95% CI [6.49, 9.39]; I2 = 89%; p < 0.001), and the range of motion (ROM) (MD 9.99, 95% CI [7.97, 12.02]; I2 = 81%; p < 0.001) in the knees when compared to the control group without using neuromuscular electrical stimulation. Existing evidence show that neuromuscular electrical stimulation is beneficial for early rehabilitation after ACL reconstruction. The use of neuromuscular electrical stimulation is encouraged in the design of rehabilitation protocol. However, due to the limited number of RCT studies and the small sample size, further multi-center RCTs with more participants are needed for a higher-level evidence


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 64 - 64
4 Apr 2023
Hartland A Islam R Teoh K Rashid M
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There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included pain (visual analogue scale VAS), rate of Popeye deformity, and operative time. 860 patients from 11 RCTs (426 tenotomy vs 434 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.14, 95% CI −0.04 to 0.32; p=0.13). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. There was no significant difference for pain (VAS). Tenodesis resulted in a lower rate of Popeye deformity (OR 0.29, 95% CI 0.19 to 0.45, p < 0.00001). Tenotomy demonstrated a shorter operative time (MD 15.21, 95% CI 1.06 to 29.36, p < 0.00001). Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. A large multi-centre clinical effectiveness randomised controlled trial is needed to provide clarity in this area


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 26 - 26
1 Dec 2021
Edwards T Daly C Donovan R Whitehouse M
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Abstract. Objectives. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Results. Nine randomised controlled trials (RCTs) and 19 observational studies fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. This study reports a significantly decreased relative risk of complications when femoral diaphyseal fractures in children aged 4 to 12 are managed with plates. The overall quality of evidence is low, highlighting the need for a prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 39 - 39
1 Jul 2022
Prodromidis A Charalambous C Moran E Venkatesh R Pandit H
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Abstract. Introduction. This study aimed to assess the effect of PRP on knee articular cartilage content (thickness and/or volume) and establish if there is a correlation between changes in cartilage and clinical outcomes in patients with knee osteoarthritis. Methodology. A systematic review was performed following the Cochrane methodology. Studies were included if they reported on cartilage content with MRI or Ultrasound before and after the injection. A random-effects model meta-analysis was performed. Results. 11 studies (n=786) from 1,453 records met the inclusion criteria, with five (n=444) being RCTs. The PRP treatment protocol varied widely. Follow-up ranged from 6–12 months. Eight studies reported increase in cartilage content in the PRP group as compared to control (four showing significant difference). In meta-analysis: PRP treatment was not associated with a significant increase in cartilage thickness in medial and lateral femoral condyle, or in the overall cartilage content (4 studies, n=187, Hedges’ g: 0.079; 95%CI: 0.358-0.516; p=0.723). Meta-analysis of 3 RCTs (n=112) showed no significant difference in increasing cartilage content overall with PRP injections compared with no PRP (Hedges’ g: 0.217; 95%CI: -0.177 – 0.611; P=0.281). There was no correlation between changes in cartilage and clinical outcomes following PRP treatment. Conclusion. Treatment of knee osteoarthritis with PRP is not associated with a significant increase in articular cartilage content and any effect on cartilage is not associated with better clinical outcomes. A multi-centre, adequately powered RCT, with a standardized preparation / administration protocol assessing long-term effect of PRP in knee osteoarthritis is needed to guide clinical care


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 104 - 104
1 Dec 2022
Kooner P Rizkallah M Sidhu R Turcotte R Aoude A
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In recent literature, the fragility index (FI) has been used to evaluate the robustness of statistically significant findings of dichotomous outcomes. This metric is defined as the minimum number of outcome events to flip study conclusions from significant to nonsignificant. Orthopaedics literature is frequently found to be fragile with a median FI of 2 in 150 RCTs across spine, hand, sports medicine, trauma and orthopaedic oncology studies. While many papers discuss limitations of FI, we aimed to further characterize it by introducing the Fragility Likelihood (FL), a new metric that allows us to consider the probability of the event to occur and to calculate the likelihood of this fragility to be reached. We systematically reviewed all randomized controlled trials in the Journal of Bone and Joint Surgery (Am) over 10 years. The FL was calculated with the following formula: A x B x C x 100% (A= FI; B = probability of the event in the group with the smallest number of events; C= probability of the non-event in the group with the highest number of events). A smaller FL demonstrates more robust results and conversely, a larger FL illustrates a higher likelihood of fragility being reached and more fragile the findings. The median FI for the statistically significant outcomes was 2 (Mean: 3.8; Range 0-23). The median FL for the statistically significant outcomes was 11% (Mean: 22%, Range: 2%-73%). This means that the probability of reaching non-significance is only 11% when considering the probability of the event to occur. When comparing studies with the same FI we found the FL to range from 3% to 43%. This illustrates the large differences in robustness between trials with equal FI when the likelihood of the event was taken into consideration. As orthopaedic studies are frequently reported as fragile, we found that by calculating the FL, studies may be more robust than previously assumed based off FI alone. By using the FL in conjunction with FI and p-values will provide additional insight into the robustness of the reported outcomes. Our results indicate that by calculating the FL, study conclusions are stronger than what the FI alone predicts. Although conducting RCTs in surgery can be challenging, we must endeavor to critically evaluate our results so we can answer important orthopaedic questions with certainty


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 532 - 539
1 Jun 2024
Lei T Wang Y Li M Hua L

Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023. Randomized controlled trials (RCTs) which evaluate the efficacy of HA, PRP, local anaesthetic, steroid, steroid+anaesthetic, HA+PRP, and physiological saline injection as a placebo, for patients with hip OA were included. Results. In this meta-analysis of 16 RCTs with a total of 1,735 participants, steroid injection was found to be significantly more effective than placebo injection on reported pain at three months, but no significant difference was observed at six months. Furthermore, steroid injection was considerably more effective than placebo injection for functional outcomes at three months, while the combination of HA+PRP injection was substantially more effective at six months. Conclusion. Evidence suggests that steroid injection is more effective than saline injection for the treatment of hip joint pain, and restoration of functional outcomes. Cite this article: Bone Joint J 2024;106-B(6):532–539


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 155 - 155
1 Nov 2021
Edwards T Daly C Donovan R Whitehouse M
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Introduction and Objective. The most common paediatric orthopaedic injury requiring hospital admission is a femoral fracture. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The National Institute for Health and Care Excellence (NICE) and the American Academy of Orthopaedic Surgeons (AAOS) have issued relevant guidelines, however, there is limited evidence to support these. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Materials and Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Secondary outcomes assessed the risk of pre-specified individual complications. Results. Nine randomised controlled trials (RCTs) and 19 observational studies (six prospective and 13 retrospective) fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN fixation (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN fixation in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. Although NICE and the AAOS recommend FIN for femoral diaphyseal fractures in children aged 4 to 12, this study reports a significantly decreased relative risk of complications when these injuries are managed with plates. Our findings provide valuable information to healthcare professionals who are involved in discussing the risk and benefits of different management options with patients and their families. The overall quality of evidence is low, highlighting the need for a rigorous prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_10 | Pages 14 - 14
1 Aug 2021
Matharu G Blom A Board T Whitehouse M
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Considerable debate exists regarding which agent(s) should be preferred for venous thromboembolism (VTE) chemical prophylaxis following joint replacement. We assessed the practice of surgeons regarding VTE chemical prophylaxis for primary THR and TKR, pre and post issuing of updated NICE guidance in 2018. A survey, circulated through the British Hip Society and regional trainee networks/collaboratives, was completed by 306 UK surgeons at 187 units. VTE chemical prophylaxis prescribing patterns for surgeons carrying out primary THR (n=258) and TKR (n=253) in low-risk patients were assessed post publication of 2018 NICE recommendations. Prescribing patterns before and after the NICE publication were subsequently explored. Questions were also asked about surgeon equipoise for participation in future RCTs. Following the new guidance, 34% (n=87) used low-molecular weight heparin (LMWH) alone, 33% (n=85) aspirin (commonly preceded by LMWH), and 31% (n=81) direct oral anticoagulants (DOACs: with/without preceding LMWH) for THR. For TKR, 42% (n=105) used aspirin (usually monotherapy), 31% (n=78) LMWH alone, and 27% (n=68) DOAC (with/without preceding LMWH). NICE guidance changed the practice of 34% of hip and 41% of knee surgeons, with significantly increased use of aspirin preceded by LMWH for THR (before=25% vs. after=73%;p<0.001), and aspirin for TKR (before=18% vs. after=84%;p<0.001). Significantly more regimens were NICE guidance compliant after the 2018 update for THR (before=85.7% vs. after=92.6%;p=0.011) and TKR (before=87.0% vs. after=98.8%;p<0.001). Support from surgeons for future RCTs was dependent on the clinical question, ranging from 48% participation in trials (effectiveness of aspirin vs. a DOAC) to 79% (effectiveness of 14 days LMWH vs. 28 days LMWH). Over one-third of surveyed surgeons changed their VTE chemical prophylaxis in response to 2018 NICE recommendations, with more THR and TKR surgeons now compliant with latest NICE guidance. The major change in practice was an increased use of aspirin for VTE chemical prophylaxis. Furthermore, there is an appetite amongst UK surgeons for participating in future RCTs, with a trial comparing standard versus extended duration LMWH likely feasible in current practice


Bone & Joint Open
Vol. 4, Issue 5 | Pages 315 - 328
5 May 2023
De Klerk TC Dounavi DM Hamilton DF Clement ND Kaliarntas KT

Aims. The aim of this study was to determine the effectiveness of home-based prehabilitation on pre- and postoperative outcomes in participants awaiting total knee (TKA) and hip arthroplasty (THA). Methods. A systematic review with meta-analysis of randomized controlled trials (RCTs) of prehabilitation interventions for TKA and THA. MEDLINE, CINAHL, ProQuest, PubMed, Cochrane Library, and Google Scholar databases were searched from inception to October 2022. Evidence was assessed by the PEDro scale and the Cochrane risk-of-bias (ROB2) tool. Results. A total of 22 RCTs (1,601 patients) were identified with good overall quality and low risk of bias. Prehabilitation significantly improved pain prior to TKA (mean difference (MD) -1.02: p = 0.001), with non-significant improvements for function before (MD -0.48; p = 0.06) and after TKA (MD -0.69; p = 0.25). Small preoperative improvements were observed for pain (MD -0.02; p = 0.87) and function (MD -0.18; p = 0.16) prior to THA, but no post THA effect was found for pain (MD 0.19; p = 0.44) and function (MD 0.14; p = 0.68). A trend favouring usual care for improving quality of life (QoL) prior to TKA (MD 0.61; p = 0.34), but no effect on QoL prior (MD 0.03; p = 0.87) or post THA (MD -0.05; p = 0.83) was found. Prehabilitation significantly reduced hospital length of stay (LOS) for TKA (MD -0.43 days; p < 0.001) but not for THA (MD, -0.24; p = 0.12). Compliance was only reported in 11 studies and was excellent with a mean value of 90.5% (SD 6.82). Conclusion. Prehabilitation interventions improve pain and function prior to TKA and THA and reduce hospital LOS, though it is unclear if these effects enhance outcomes postoperatively. Cite this article: Bone Jt Open 2023;4(5):315–328


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 622 - 634
1 Jun 2023
Simpson CJRW Wright E Ng N Yap NJ Ndou S Scott CEH Clement ND

Aims. This systematic review and meta-analysis aimed to compare the influence of patellar resurfacing following cruciate-retaining (CR) and posterior-stabilized (PS) total knee arthroplasty (TKA) on the incidence of anterior knee pain, knee-specific patient-reported outcome measures, complication rates, and reoperation rates. Methods. A systematic review of MEDLINE, PubMed, and Google Scholar was performed to identify randomized controlled trials (RCTs) according to search criteria. Search terms used included: arthroplasty, replacement, knee (Mesh), TKA, prosthesis, patella, patellar resurfacing, and patellar retaining. RCTs that compared patellar resurfacing versus unresurfaced in primary TKA were included for further analysis. Studies were evaluated using the Scottish Intercollegiate Guidelines Network assessment tool for quality and minimization of bias. Data were synthesized and meta-analysis performed. Results. There were 4,135 TKAs (2,068 resurfaced and 2,027 unresurfaced) identified in 35 separate cohorts from 33 peer-reviewed studies. Anterior knee pain rates were significantly higher in unresurfaced knees overall (odds ratio (OR) 1.84; 95% confidence interval (CI) 1.20 to 2.83; p = 0.006) but more specifically associated with CR implants (OR 1.95; 95% CI 1.0 to 3.52; p = 0.030). There was a significantly better Knee Society function score (mean difference (MD) -1.98; 95% CI -1.1 to -2.84; p < 0.001) and Oxford Knee Score (MD -2.24; 95% CI -0.07 to -4.41; p = 0.040) for PS implants when patellar resurfacing was performed, but these differences did not exceed the minimal clinically important difference for these scores. There were no significant differences in complication rates or infection rates according to implant design. There was an overall significantly higher reoperation rate for unresurfaced TKA (OR 1.46 (95% CI 1.04 to 2.06); p = 0.030) but there was no difference between PS or CR TKA. Conclusion. Patellar resurfacing, when performed with CR implants, resulted in lower rates of anterior knee pain and, when used with a PS implant, yielded better knee-specific functional outcomes. Patellar resurfacing was associated with a lower risk of reoperation overall, but implant type did not influence this. Cite this article: Bone Joint J 2023;105-B(6):622–634


Abstract. Objectives. To determine the effects of self-management interventions (SMIs) including an exercise component (EC) on low back pain (LBP) and disability and to determine whether SMIs with tailored exercises (TEs) have superior outcomes compared to SMIs with general exercises (GEs). Methods. An electronic systematic search of randomized controlled trials (RCTs) was performed in 5 electronic databases. RCTs compared SMIs with an EC to control interventions. Data were extracted at 3 follow-up points (short-term, intermediate and long-term) and meta-analyses were performed. Reviewed RCTs were divided into subgroups based on whether the EC was tailored or generic. A subgroup meta-analysis was performed at the short-term follow-up to assess whether the SMIs with TEs have superior outcomes compared to SMIs with GEs. Results. 12 original RCTs were included in the review (six including SMIs with TEs) and were of moderate quality. The pooled results revealed the effect sizes (ESs) of −0.26,-0.32 and −0.21 for short, intermediate and long-term pain intensity, respectively and −0.26,-0.22 and −0.21 for short, intermediate, and long-term disability, respectively (negative value indicates a mean difference in favour of SMIs) indicating a moderate but significant reduction in pain and disability compared to controls. Subgroup meta-analysis at the short-term follow-up revealed that SMIs with TEs had ES of –0.19(p=0.004) for pain and –0.20(p=0.002) for disability compared to SMIs with GEs demonstrating positive but not significant improvement in pain (ES −0.48, p=0.09) and disability (ES −0.45, p=0.10). Conclusions. There is moderate quality evidence for SMIs with an EC to have moderate but significant positive effect on pain and disability in people with LBP. The subgroup analysis revealed that SMIs with exercises tailored to person's needs are superior in reducing pain and disability. These results indicate the importance of developing TE solutions supporting self-management to improve its effect on pain and disability in LBP patients. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 34 - 34
1 Oct 2019
Wood L Foster N Lewis M Bishop A
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Background and Aim of Study. Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we observed 30 direct and indirect treatment targets of exercise described across 23 RCTs for persistent NSLBP. Since not all treatment targets and outcomes can be assessed in all RCTs, it is therefore important to prioritise these treatment targets through consensus from key stakeholders. These consensus workshops aimed to agree treatment targets for the use of exercise interventions in randomised controlled trials (RCTs) in persistent NSLBP using nominal group workshop (NGW) methodology. Methods and Results. The first UK workshop included people who had experience of exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design exercise interventions tested in RCTs. The second workshop included participants attending an international back and neck pain research workshop. Twelve participants took part in the UK NGW and fifteen took part in the final ranking of the exercise treatment targets. In addition to the original list of 30 treatment targets, a further 26 ideas were generated. After grouping and voting, 18 treatment targets were prioritised. The top five ranked targets of exercise interventions for persistent NSLBP were: pain reduction, improvement in function, reduction of fear of movement, encouragement of normal movement and improvement of mobility. The results of the international NGW will also be presented. Conclusion. Future RCTs of exercise should consider more consistent assessment of these treatment targets. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Conflicts of Interest: No conflicts of interest


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 35 - 35
1 Nov 2021
Hartland A Islam R Teoh K Rashid M
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Introduction and Objective. There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. Materials and Methods. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included visual analogue scale (VAS), rate of cosmetic deformity (Popeye sign), range of motion, operative time, and elbow flexion strength. Results. 751 patients from 10 RCTs demonstrated (369 tenotomy vs 382 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.17 95% CI −0.02 to 0.36, p=0.09). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. Secondary outcomes including VAS, shoulder external rotation, and elbow flexion strength did not reveal any significant difference. Tenodesis resulted in a lower rate of Popeye deformity (OR 0.27 95% CI 0.16 to 0.45, p<0.00001). Conclusions. Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. This finding was irrespective of the whether the rotator cuff was intact


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 27 - 27
1 Dec 2021
Edwards T Donovan R Whitehouse M
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Abstract. Objectives. Intra-articular corticosteroid injections (IACIs) are a well-established non-surgical treatment for the symptoms of osteoarthritis (OA), which can provide short-term improvements in pain, disability and quality of life (QoL). Many patients receive recurrent IACIs as temporary relief of their symptoms. Longer-term outcomes for recurrent IACIs remain less well-researched. This meta-analysis aimed to investigate the longer-term risks and benefits of IACIs beyond 3 months. Methods. We searched MEDLINE, EMBASE, and CENTRAL from inception to January 07, 2021, for randomised controlled trials (RCTs) where patients with OA had received recurrent IACIs. Our primary outcomes were pain and function. Secondary outcomes included QoL, disease progression, radiological changes, and adverse events. Mean differences with 95% confidence intervals were reported. Results. Ten RCTs met eligibility criteria (eight for knee OA [n=378], two for trapeziometacarpal OA [n=57]). Patients received 2–5 injections. Follow-up ranged from 6–24 months. Patients with knee OA showed mild improvement in pain at 3, 6, and 9 months but not at 12 months post-injection compared to baseline. Improvements in function were seen from 3–24 months post-injection, decreasing over time. Improvements in QoL continued at 24 months. For patients with trapeziometacarpal OA, mild improvements in pain, function, and QoL were demonstrated at 3–6 months (and 12 months for pain) compared to baseline. No serious adverse events were recorded. No studies reported on time-to-future interventions, or risk of future periprosthetic joint infection. Conclusions. Only mild improvements in pain, function, and QoL were noted after recurrent IACIs up to 6–24 months post-injection. Existing RCTs on recurrent IACI lacks sufficient follow-up data to assess disease progression and time-to-future interventions. These results will inform the RecUrrent Intra-articular Corticosteroid injections in Osteoarthritis (RUbICOn) study which aims to establish the long-term safety outcomes of IACI through data linkage of clinical practice data, hospital episode statistics, and national PROMs


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 33 - 33
1 Nov 2021
Hartland A Teoh K Rashid M
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Introduction and Objective. Tranexamic acid (TXA) is used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in trauma, spinal surgery, and lower limb arthroplasty. The aim of this study is to investigate the clinical effectiveness of TXA in all types of shoulder surgery on bleeding and non-bleeding related outcomes. Materials and Methods. This study was registered prospectively on the PROSPERO database (ref: CRD42020185482). A systematic review and meta-analysis of randomised controlled trials (RCTs) investigating intra-operative use of TXA versus placebo in any type of surgery to the shoulder girdle. Electronic databases searched included MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and Jadad score. Certainty of findings were reported using the GRADE approach. The primary outcome was total blood loss. Secondary outcomes included patient reported outcome measures, adverse events, and rate of blood transfusion. Results. Eight RCTs were included in the systematic review and data from 7 of these studies pooled in the meta-analysis. A total of 708 patients were randomized across the studies (406 received TXA, 302 received placebo). Studies included patients undergoing anatomic or reverse total shoulder arthroplasty, open Latarjet surgery, and arthroscopic rotator cuff repair. Pooled analysis demonstrated significant reduction in perioperative bleeding with TXA compared to controls; estimated total blood loss (mean difference [MD], −209.66; 95% CI −389.11 to −30.21; p=0.02), and post-operative blood loss (via drain output) (MD, −84.8ml; 95% CI, −140.04 to −29.56; p=0.003). A mean difference in Visual Analogue Scale (VAS) of 2.93 was noted in favour of TXA (95% CI 0.2 to 5.66; p=0.04). Conclusions. Whilst noting some risk of bias within the studies, TXA was effective in reducing blood loss and pain in shoulder surgery. There may be a benefit of TXA use in both open and arthroscopic shoulder procedures. Larger, low risk of bias, RCTs for specific surgical shoulder procedures are required


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


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 68 - 68
1 Mar 2021
AlFayyadh F Farii HA Farahdel L Turcotte R Frazer A
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The aim was to analyze the efficacy of zoledronic acid (ZA) versus denosumab in the prevention of pathological fractures in patients with bone metastases from advanced cancers by evaluating all available randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed and MEDLINE) was performed to identify all published RCTs comparing zoledronic acid with denosumab in prevention of pathological fractures in bone metastases. Risk of bias of the studies was assessed. The primary outcomes evaluated were pathological fractures. Four RCTs (7320 patients) were included. Denosumab was superior to ZA in reducing the likelihood of pathological fractures, when all tumour types were combined (OR 0.86, 95% CI [0.74, 0.99], p = 0.04). Denosumab was not significantly favoured over ZA in endodermal origin (breast and prostate) (OR 0.85, 95% CI [0.68, 1.05], p = 0.13) and mesodermal origin tumours (solid tumours and MM) (OR 0.87, 95% CI [0.71, 1.06], p = 0.16). Denosumab significantly reduces the likelihood of pathological fractures in comparison to ZA in patients with bone metastases. When pathological fractures were grouped by tumour origin (endodermal or mesodermal), there was no significant difference between denosumab and ZA. Further long-term studies are needed to confirm the effectiveness of these treatment regimens


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


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 13 - 13
1 Oct 2022
Webber R Reddington M Arris S Mawson S
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Background. Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review. Method. Population, context, selection criteria, intervention(s), control, outcome measures, how the intervention was hypothesised to produce outcomes and author recommendations based on results of the study were extracted from text records. The extent to which the advice included matched a published international consensus statement on evidence-based advice for back pain was recorded. Whether interventions or settings were complex was determined using the Medical Research Council complex intervention development and evaluation guidance and the extent to which they met complexity reporting criteria was recorded. Results. The review included 26 trials conducted over 25 years. Differences In causal pathways could explain diversity in intervention design but these were not clearly described or evaluated. All studies were complex in terms of intervention and setting. This was rarely considered in intervention and trial design or when discussing the results. Although interventions were frequently described in detail only a few explained the process and justification of the design. Theories of education or behaviour change were rarely applied. Conclusion. These studies have not deepened our understanding of how education improves outcomes. Future RCTs should engage more with theory and other theory-based research methods should to be considered. Conflict of interest: No conflicts of interest. Sources of funding: No funding


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 15 - 15
1 Dec 2020
Haider Z Aweid B Subramanian P Iranpour F
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Telemedicine is the delivery of healthcare from a remote location using integrated computer/communication technology. This systematic review aims to explore evidence for telemedicine in orthopaedics to determine its advantages, validity, effectiveness and utilisation particularly during our current pandemic where patient contact is limited. Databases of PubMed, Scopus and CINHAL were systematically searched and articles were included if they involved any form of telephone or video consultation in an orthopaedic population. Findings were synthesised into four themes: patient/clinician satisfaction, accuracy and validity of examination, safety and patient outcomes and cost effectiveness. Quality assessment was undertaken using Cochrane and Joanna Briggs Institute appraisal tools. Twenty studies were included consisting of nine RCTs across numerous orthopaedic subspecialties including fracture care, elective orthopaedics and oncology. Studies revealed high patient satisfaction with telemedicine for convenience, less waiting and travelling time. Telemedicine was cost effective particularly if patients had to travel long distances, required hospital transport or time off work. No clinically significant differences were found in patient examination nor measurement of patient reported outcome measures. Telemedicine was reported to be a safe method of consultation. However, studies were of variable methodological quality with selection bias. In conclusion, evidence suggests that telemedicine in orthopaedics can be safe, cost effective, valid in clinical assessment with high patient/clinician satisfaction. Further work with high quality RCTs is required to elucidate long term outcomes. This systematic review presents up-to-date evidence on the use of telemedicine and provides data for organisations considering its use in the current COVID-19 pandemic and beyond


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 57 - 57
4 Apr 2023
Tariq M Uddin Q Amin H Ahmed B
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This study aims to compare the outcomes of Volar locking plating (VLP) versus percutaneous Kirschner wires (K-wire) fixation for surgical management of distal radius fractures. We systematically searched multiple databases, including MEDLINE for randomized controlled trials (RCTs) comparing outcomes of VLP fixation and K-wire for treatment of distal radius fracture in adults. The methodological quality of each study was assessed by the Cochrane Risk of Bias tool. Patient-reported outcomes, functional outcomes, and complications at 1 year follow up were evaluated. Meta-analysis was performed using random-effects models and results presented as risk ratios (RRs) or mean differences (MDs) with 95% confidence interval (CI). 13 RCTs with 1336 participants met the inclusion criteria. Disabilities of the Arm, Shoulder and Hand (DASH) scores were significantly better for VLP fixation (MD= 2.15; 95% CI, 0.56-3.74; P = 0.01; I2=23%). No significant difference between the two procedures for grip strength measured in kilograms (MD= −3.84; 95% CI,-8.42-0.74; P = 0.10; I2=52%) and Patient-Rated Wrist Evaluation (PRWE) scores (MD= −0.06; 95% CI,-0.87-0.75; P = 0.89; I2=0%). K-wire treatment yielded significantly improved extension (MD= −4.30; P=0.04) but with no differences in flexion, pronation, supination, and radial deviation (P >0.05). The risk of complications and rate of reoperation were similar for the two procedures (P >0.05). This meta-analysis suggests that VLP fixation improves DASH score at 12 months follow up, however, the difference is small and unlikely to be clinically important. Existing literature does not provide sufficient evidence to demonstrate the superiority of either VLP or K-wire treatment in terms of patient-reported outcomes, functional outcomes, and complications


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 67 - 67
1 Dec 2022
Cohen D Le N Zakharia A Blackman B Slawaska-Eng D de SA D
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To determine in skeletally mature patients with a traumatic, first-time, patellar dislocation, the effect of early MPFL reconstruction versus rehabilitation on the rate of recurrent patellar dislocations and functional outcomes. Three online databases MEDLINE, EMBASE and PubMed were searched from database inception (1946, 1974, 1966 respectively), to August 20th, 2021, for literature addressing the management of patients sustaining acute first-time patellar dislocations. Data on redislocation rates, functional outcomes using the Kujala score, and complication rates were recorded. A meta-analysis was used to pool the mean postoperative kujala score as well as calculate the proportion of patients sustaining redislocation episodes using a random effects model. A risk of bias assessment was performed for all included studies using the MINORS and Detsky scores. Overall, there were a total of 22 studies and 1705 patients included in this review. The pooled mean redislocation rate in 18 studies comprising 1409 patients in the rehabilitation group was 31% (95% CI 25%-36%, I2 = 65%). Moreover, the pooled mean redislocation rate in five studies comprising 318 patients undergoing early MPFL reconstruction was 7% (95% CI 2%-17%, I2 = 70%). The pooled mean postoperative Kujala anterior knee pain score in three studies comprising 67 patients in the reconstructive group was 91 (95% CI 84-97, I2 = 86%), compared to a score of 81 (95% CI 78-85, I2 = 78%) in 7 studies comprising 332 patients in the rehabilitation group. The reoperation rate was 9.0% in 936 patients in the rehabilitation group and 2.2% in 322 patients in the reconstruction group. Management of acute first-time patellar dislocations with MPFL reconstruction resulted in a lower rate of redislocation and a higher Kujala score, as well as noninferiority with respect to complication rates compared to nonoperative treatment. The paucity of high-level evidence warrants further investigation in this topic in the form of well-designed and high-powered RCTs to determine the optimal management option in these patients


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 12 - 12
1 Sep 2019
Wood L Foster N Lewis M Bishop A
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Background. Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT. Methods and Results. A computer-aided literature search was performed in eight databases, from inception to August 2018. Inclusion criteria: RCTs in CLBP, exercise compared to a non-exercise arm, sample size >60 per arm. Title and abstract review, subsequent full text review, data extraction and risk of bias assessment were independently undertaken by pairs of reviewers. Of 18251 initially identified titles and abstracts, 23 trials were included in the review. 30 treatment targets were extracted, and 6 primary outcome domains identified. A logic model of the treatment targets and outcomes demonstrated diverse relationships. Only 5 RCTs matched their primary outcome domain to the identified treatment targets, 12 used primary outcomes that did not match the reported treatment targets, and 6 were partially matched. Conclusion. The majority of included trials did not match the primary outcome domain to the treatment targets of the exercise intervention. Further research will explore if better matching between treatment targets and outcomes may change the conclusions of exercise trials in CLBP. No conflicts of interest. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 830 - 839
1 May 2021
Ahmed I Chawla A Underwood M Price AJ Metcalfe A Hutchinson CE Warwick J Seers K Parsons H Wall PDH

Aims. Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. Methods. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. Results. We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). Conclusion. TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830–839


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1052 - 1061
1 Aug 2014
Thienpont E Schwab PE Fennema P

We conducted a meta-analysis, including randomised controlled trials (RCTs) and cohort studies, to examine the effect of patient-specific instruments (PSI) on radiological outcomes after total knee replacement (TKR) including: mechanical axis alignment and malalignment of the femoral and tibial components in the coronal, sagittal and axial planes, at a threshold of > 3º from neutral. Relative risks (RR) for malalignment were determined for all studies and for RCTs and cohort studies separately. Of 325 studies initially identified, 16 met the eligibility criteria, including eight RCTs and eight cohort studies. There was no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKR across all studies (RR = 0.84, p = 0.304), in the RCTs (RR = 1.14, p = 0.445) or in the cohort studies (RR = 0.70, p = 0.289). The results for the alignment of the tibial component were significantly worse using PSI TKR than conventional TKR in the coronal and sagittal planes (RR = 1.75, p = 0.028; and RR = 1.34, p = 0.019, respectively, on pooled analysis). PSI TKR showed a significant advantage over conventional TKR for alignment of the femoral component in the coronal plane (RR = 0.65, p = 0.028 on pooled analysis), but not in the sagittal plane (RR = 1.12, p = 0.437). Axial alignment of the tibial (p = 0.460) and femoral components (p = 0.127) was not significantly different. We conclude that PSI does not improve the accuracy of alignment of the components in TKR compared with conventional instrumentation. Cite this article: Bone Joint J 2014; 96-B:1052–61


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 98 - 98
2 Jan 2024
Mehta S Goel A Mahajan U Reddy N Bhaskar D
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Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6-8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs


Bone & Joint Research
Vol. 9, Issue 10 | Pages 653 - 666
7 Oct 2020
Li W Li G Chen W Cong L

Aims. The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. Methods. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed. Results. Ten RCTs with 713 patients and 3,331 pedicle screws were included. Compared with CT, the accuracy rate of RA was superior in Grade A with statistical significance and Grade A + B without statistical significance. Compared with CT, the operating time of RA was longer. The difference between RA and CT was statistically significant in radiation dose. Proximal facet joint violation occurred less in RA than in CT. The postoperative Oswestry Disability Index (ODI) of RA was smaller than that of CT, and there were some interesting outcomes in our subgroup analysis. Conclusion. RA technique could be viewed as an accurate and safe pedicle screw implantation method compared to CT. A robotic system equipped with optical intraoperative navigation is superior to CT in accuracy. RA pedicle screw insertion can improve accuracy and maintain stability for some challenging areas. Cite this article: Bone Joint Res 2020;9(10):653–666


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 12 - 12
7 Jun 2023
Qayum K Ng Z Sudarshan V Kudhail K Sapra H Guerero D Daoub A
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Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA. Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI). Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events. Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 1 - 1
17 Nov 2023
Mehta S Goel A Mahajan U Reddy R Bhaskar D
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Abstract. Introduction. Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Aims. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Methods. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. Results. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6–8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). Conclusion. DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 99 - 99
4 Apr 2023
Lu V Tennyson M Fortune M Zhou A Krkovic M
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Fragility ankle fractures are traditionally managed conservatively or with open reduction internal fixation (ORIF). Tibiotalocalcaneal (TTC) fusion is an alternative option for the geriatric patient. This systematic review and meta-analysis provides a detailed analysis of the functional and clinical outcomes of hindfoot nailing for fragility ankle fractures presented so far in the literature. A systematic search was performed on MEDLINE, EMBASE, Cochrane Library, Scopus, Web of Science, identifying fourteen studies for inclusion. Studies including patients over 60 with a fragility ankle fracture, treated with TTC nail were included. Patients with a previous fracture of the ipsilateral limb, fibular nails, and pathological fractures were excluded. Subgroup analyses were performed according to (1) open vs closed fractures, (2) immediate post-operative FWB vs post-operative NWB, (3) majority of cohort are diabetics vs minority of cohort are diabetics. Meta-regression analyses were done to explore sources of heterogeneity, and publication bias was assessed using Egger's test. The pooled proportion of superficial infection, deep infection, implant failure, malunion, and all-cause mortality was 0.10 (95%CI:0.06-0.16; I2=44%), 0.08 (95%CI:0.06-0.11, I2=0%), 0.11 (95%CI:0.07-0.15, I2=0%), 0.11 (95%CI:0.06-0.18; I2=51%), and 0.27 (95%CI:0.20-0.34; I2=11%), respectively. The pooled mean post-operative OMAS score was 54.07 (95%CI:48.98-59.16; I2=85%). The best-fitting meta-regression model included age and percentage of male patients as covariates (p=0.0263), and were inversely correlated with higher OMAS scores. Subgroup analyses showed that studies with a majority of diabetics had a higher proportion of implant failure (p=0.0340) and surgical infection (p=0.0096), and a lower chance of returning to pre-injury mobility than studies with a minority of diabetics (p=0.0385). Egger's test (p=0.56) showed no significant publication bias. TTC nailing is an adequate alternative option for fragility ankle fractures. However, current evidence includes mainly case series with inconsistent outcome measures reported and post-operative rehabilitation protocols. Prospective RCTs with long follow-up times and large cohort sizes are needed to clearly guide the use of TTC nailing for ankle fractures


The Bone & Joint Journal
Vol. 99-B, Issue 1 | Pages 94 - 99
1 Jan 2017
Kim JM Zimmerman RM Jones CM Muhit AA Higgins JP Means Jr KR

Aims. Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics. Materials and Methods. Based on five-year mean impact factors, we selected the six journals that routinely publish studies of upper extremity surgery. Using a journal-specific search query, 62 RCTs met our inclusion criteria. Then three blinded reviewers used the Jadad and revised Coleman Methodology Score (RCMS) to assess the quality of the manuscripts. Results. Based on the Jadad scale, 28 studies were of high quality and 34 were of low quality. Methodological deficiencies in poorly scoring trials included the absence of rate of enrolment, no power analysis, no description of withdrawal or dropout, and a failure to use validated outcomes assessments with an independent investigator. Conclusion. A large number of RCTs in hand, wrist, and elbow surgery were of suboptimal quality when judged against the RCMS and Jadad scales. Even with a high level of evidence, study design and execution of RCTs should be critically assessed. Methodological deficiencies may introduce bias and lead to statistically underpowered studies. Cite this article: Bone Joint J 2017;99-B:94–9


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. 95-B, Issue 7 | Pages 935 - 941
1 Jul 2013
Moor BK Bouaicha S Rothenfluh DA Sukthankar A Gerber C

We hypothesised that a large acromial cover with an upwardly tilted glenoid fossa would be associated with degenerative rotator cuff tears (RCTs), and conversely, that a short acromion with an inferiorly inclined glenoid would be associated with glenohumeral osteoarthritis (OA). This hypothesis was tested using a new radiological parameter, the critical shoulder angle (CSA), which combines the measurements of inclination of the glenoid and the lateral extension of the acromion (the acromion index). The CSA was measured on standardised radiographs of three groups: 1) a control group of 94 asymptomatic shoulders with normal rotator cuffs and no OA; 2) a group of 102 shoulders with MRI-documented full-thickness RCTs without OA; and 3) a group of 102 shoulders with primary OA and no RCTs noted during total shoulder replacement. The mean CSA was 33.1° (26.8° to 38.6°) in the control group, 38.0° (29.5° to 43.5°) in the RCT group and 28.1° (18.6° to 35.8°) in the OA group. Of patients with a CSA > 35°, 84% were in the RCT group and of those with a CSA < 30°, 93% were in the OA group. We therefore concluded that primary glenohumeral OA is associated with significantly smaller degenerative RCTs with significantly larger CSAs than asymptomatic shoulders without these pathologies. These findings suggest that individual quantitative anatomy may imply biomechanics that are likely to induce specific types of degenerative joint disorders. Cite this article: Bone Joint J 2013;95-B:935–41


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 60 - 60
1 Aug 2020
Farii HA Farahdel L Salimi A
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The aim was to analyze whether non-steroidal anti-inflammatory drugs (NSAIDs) have an adverse effect on bone healing by evaluating all available human randomized controlled trials (RCTs) on this subject. A systematic search of electronic databases (PubMed, MEDLINE, and Cross-References) was performed to identify RCTs comparing the occurrence of nonunion in patients who received NSAIDs to the control group. Risk of bias of the studies was assessed. Nonunion was the main outcome evaluated, however, regression analysis was used to estimate the relative risk comparing duration and type of NSAIDs. Six RCTs (609 patients) were included. The risk of nonunion was higher in the patients given NSAIDs after the fracture (P-value= 0.0009, relative risk [RR] = 2.9, 95% confidence interval [CI] = 1.6 to 6.3). However, once the studies have been categorized to the duration of NSAIDs, those who received short period of NSAIDs (4 weeks) (P-value = 0.0002, RR = 4.1, CI = 2.1 to 8). Also, indomethacin agent has associated with high nonunion (P-value = 0.0001, RR = 3.9, CI = 2.3 to 13.9) compared to other NSAIDs which did not show a nonunion risk (P-value = 0.24, RR = 2.3, CI = 0.6 to 8.9). Using NSAIDs for long period (> 4 weeks) after fracture is significantly associated with nonunion especially with indomethacin agent. However, short period of NSAIDs (< 2 weeks) did not show the adverse effects of nonunion. Overall, further studies are required to support our conclusion


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 19 - 19
7 Aug 2024
Foster NE Bada E Window P Stovell M Ahuja S Beard D Gardner A
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Background and Purpose. The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs. Methods. Two online cross-sectional surveys distributed via UK and Australian professional networks to clinicians involved in LBP care, collected data on clinical discipline, practice setting and preferred care of five patient cases (ranging in age, pain duration, BMI, imaging findings, neurological signs/symptoms). Clinicians were also asked about willingness to randomise each patient case. Results. Of 174 responses (73 UK, 101 Australia), 70 were orthopaedic surgeons, 34 neurosurgeons, 65 allied health professionals (AHPs), 5 others. Most worked in public health services only (92% UK, 45% Australia), or a mix of public/private (36% Australia). Most respondents chose BCC as their first-choice management option for all five cases (81–93% UK, 83–91% Australia). For LFS, UK surgeons preferred TLIF (36.4%), whereas Australian surgeons preferred ALIF (54%). Willingness to randomise cases ranged from 37–60% (UK mean 50.7%), and 47–55% (Australian mean 51.9%); orthopaedic and neuro-surgeons were more willing than AHPs. Conclusion. Whilst BCC was preferred for all five patient cases, just over half of survey respondents in both the UK and Australia were willing to randomise cases to either LFS or BCC, indicating clinical equipoise (collective uncertainty) needed for RCT recruitment. Conflicts of interest. None. Sources of funding. No specific funding obtained for the surveys. DB, SA, AG and NEF have funding from the National Institute for Health Research (NIHR) UK (FORENSIC-UK NIHR134859); NEF, DB and SA have funding from the Australian National Health and Medical Research Council (NHMRC FORENSIC-Australia GA268233). AG has funding from Orthopaedic Research UK (combined with British Association of Spine Surgeons and British Scoliosis Society) and Innovate UK. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182)


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 63 - 63
1 Mar 2021
Bozzo A Deng J Bhasin R Deodat M Abbas U Wariach S Axelrod D Masrouha K Wilson D Ghert M
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Lung cancer is the most common cancer diagnosed, the leading cause of cancer-related deaths, and bone metastases occurs in 20–40% of lung cancer patients. They often present symptomatically with pain or skeletal related events (SREs), which are independently associated with decreased survival. Bone modifying agents (BMAs) such as Denosumab or bisphosphonates are routinely used, however no specific guidelines exist from the National Comprehensive Cancer Center or the European Society of Medical Oncologists. Perhaps preventing the formation of guidelines is the lack of a high-quality quantitative synthesis of randomized controlled trial (RCT) data to determine the optimal treatment for the patient important outcomes of 1) Overall survival (OS), 2) Time to SRE, 3) SRE incidence, and 4) Pain Resolution. The objective of this study was to perform the first systematic review and network meta-analysis (NMA) to assess the best BMA for treatment of metastatic lung cancer to bone. We conducted our study in accordance to the PRISMA protocol. We performed a librarian assisted search of MEDLINE, PubMed, EMBASE, and Cochrane Library and Chinese databases including CNKI and Wanfang Data. We included studies that are RCTs reporting outcomes specifically for lung cancer patients treated with a bisphosphonate or Denosumab. Screening, data extraction, risk of bias and GRADE were performed in duplicate. The NMA was performed using a Bayesian probability model with R. Results are reported as relative risks, odds ratios or mean differences, and the I2 value is reported for heterogeneity. We assessed all included articles for risk of bias and applied the novel GRADE framework for NMAs to rate the quality of evidence supporting each outcome. We included 132 RCTs comprising 11,161 patients with skeletal metastases from lung cancer. For OS, denosumab was ranked above zoledronic acid (ZA) and estimated to confer an average of 3.7 months (95%CI: −0.5 – 7.6) increased survival compared to untreated patients. For time to SRE, denosumab was ranked first with an average of 9.1 additional SRE-free months (95%CI: 4.0 – 14.0) compared to untreated patients, while ZA conferred an additional 4.8 SRE-free months (2.4 – 7.0). Patients treated with the combination of Ibandronate and systemic therapy were 2.3 times (95%CI: 1.7 – 3.2) more likely to obtain successful pain resolution, compared to untreated. Meta-regression showed no effect of heterogeneity length of follow-up or pain scales on the observed treatment effects. Heterogeneity in the network was considered moderate for overall survival and time to SRE, mild for SRE incidence, and low for pain resolution. While a generally high risk of bias was observed across studies, whether they were from Western or Chinese databases. The overall GRADE for the evidence underlying our results is High for Pain control and SRE incidence, and Moderate for OS and time to SRE. This study represents the most comprehensive synthesis of the best available evidence guiding pharmacological treatment of bone metastases from lung cancer. Denosumab is ranked above ZA for both overall survival and time to SRE, but both treatments are superior to no treatment. ZA was first among all bisphosphonates assessed for odds of reducing SRE incidence, while the combination of Ibandronate and radionuclide therapy was most effective at significantly reducing pain from metastases. Clinicians and policy makers may use this synthesis of all available RCT data as support for the use of a BMA in MBD for lung cancer


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_5 | Pages 5 - 5
23 Apr 2024
Sain B Sidharthan S Naique S
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Introduction. Treatment of non-union in open tibial fractures Gustilo-Anderson(GA)-3A/3B fractures remains a challenging problem. Most of these can be dealt using treatment methods that requires excision of the non-union followed by bone grafting, masquelet technique, or acute shortening. Circular fixators with closed distraction or bone transport also remains a useful option. However, sometimes due to patient specific factors these cannot be used. Recently antibiotic loaded bone substitutes have been increasingly used for repairing infected non-unions. They provide local antibiotic delivery, fill dead space, and act as a bone conductive implant, which is resorted at the end of a few months. We aimed to assess the outcome of percutaneous injection of bone substitute while treating non-union of complex open tibial fractures. Materials & Methods. Three cases of clinical and radiological stiff tibial non-union requiring further intervention were identified from our major trauma open fracture database. Two GA-3B cases, treated with a circular frame developed fracture-related-infection(FRI) manifesting as local cellulitis, loosened infected wires/pins with raised blood-markers, and one case of GA-3A treated with an intramedullary nail. At the time of removal of metalwork/frame, informed consent was obtained and Cerament-G. TM. (bone-substitute with gentamicin) was percutaneously injected through a small cortical window using a bone biopsy(Jamshedi needle). All patients were allowed to weight bear as tolerated in a well-fitting air-cast boot and using crutches. They were followed up at 6 weekly intervals with clinical assessment of their symptoms and radiographs. Fracture union was assessed using serial radiographs with healing defined as filling of fracture gap, bridging callus and clinical assessment including return to full painless weight bearing. Results. Follow-up at 6 months showed all fractures had healed with no defect or gaps with evidence of new trabecular bone and significant resorption of Cerament-G. TM. at final follow-up. There was no evidence of residual infection with restoration of normal limb function. Fractures with no internal fixation showed a mild deformity that had developed during the course of the healing, presumed due to mild collapse in the absence of fixation. These were less than 10 degrees in sagittal and coronal planes and were clinically felt to be insignificant by the patients. Conclusions. Cerament-G's unique combination of high dose antibiotics and hydroxy apatite matrix provided by calcium sulphate might help provide an osteoconductive environment to allow these stiff non-unions to heal. The matrix appears to provide a scaffold-like structure that allows new bone in-growth with local release of antibiotics helping reduce deep-seated infections. The final deformation at fracture site underlines the need for fixation- and it is very unlikely that this technique will work in mobile nonunions. Whilst similar fractures may heal without the use of bone substitute injections, the speed of healing in presence of significant fracture gap suggests the use of these bone substitutes did help in our cases. Further studies with a larger cohort, including RCTs, to evaluate the effectiveness of this technique compared to other methods are needed


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1113 - 1121
14 Sep 2020
Nantha Kumar N Kunutsor SK Fernandez MA Dominguez E Parsons N Costa ML Whitehouse MR

Aims. We conducted a systematic review and meta-analysis to compare the mortality, morbidity, and functional outcomes of cemented versus uncemented hemiarthroplasty in the treatment of intracapsular hip fractures, analyzing contemporary and non-contemporary implants separately. Methods. PubMed, Medline, EMBASE, CINAHL, and Cochrane Library were searched to 2 February 2020 for randomized controlled trials (RCTs) comparing the primary outcome, mortality, and secondary outcomes of function, quality of life, reoperation, postoperative complications, perioperative outcomes, pain, and length of hospital stay. Relative risks (RRs) and mean differences (with 95% confidence intervals (CIs)) were used as summary association measures. Results. A total of 18 studies corresponding to 16 non-overlapping RCTs with a total of 2,819 intracapsular hip fractures were included. Comparing contemporary cemented versus uncemented hemiarthroplasty, RRs (95% CIs) for mortality were 1.32 (0.44 to 3.99) perioperatively, 1.01 (0.48 to 2.10) at 30 days, and 0.90 (0.71 to 1.15) at one year. The use of contemporary cemented hemiarthroplasty reduced the risk of intra- and postoperative periprosthetic fracture. There were no significant differences in the risk of other complications, function, pain, and quality of life. There were no significant differences in perioperative outcomes except for increases in operating time and overall anaesthesia for contemporary cemented hemiarthroplasty with mean differences (95% CIs) of 6.67 (2.65 to 10.68) and 4.90 (2.02 to 7.78) minutes, respectively. The morbidity and mortality outcomes were not significantly different between non-contemporary cemented and uncemented hemiarthroplasty. Conclusion. There are no differences in the risk of mortality when comparing the use of contemporary cemented with uncemented hemiarthroplasty in the management of intracapsular hip fractures. Contemporary cemented hemiarthroplasty is associated with a substantially lower risk of intraoperative and periprosthetic fractures. Cite this article: Bone Joint J 2020;102-B(9):1113–1121


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 282 - 282
1 May 2009
Hettinga D
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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 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. 101-B, Issue SUPP_9 | Pages 32 - 32
1 Sep 2019
Lemmers G van Lankveld W van der Wees P Westert G Staal J
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Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS. Randomized controlled trials (RCTs) and observational studies (OSs), comparing imaging versus no imaging on targeted outcomes were extracted from medical databases until October 2017. Data extraction and risk of bias assessment was performed independently by two reviewers. The quality of the body of evidence was determined using GRADE methodology. Results. Moderate quality evidence (1 RCT; n=421) supports that direct costs increase for patients undergoing radiography. Low quality evidence (3 OSs; n=9535) supports that early MRI leads to a large increase in costs. Moderate quality evidence (2 RCTs, 6 OSs; n=19392) supports that performing MRI, radiography or CT is associated with increased healthcare utilization. Two RCTs (n=667) showed no significant differences between radiography or MRI groups compared with no imaging groups on absence from work. However, the results of two observational studies (n=7765) did show significantly greater absence from work in the imaging groups compared to the no imaging-groups. Conclusions. Imaging in LBP is associated with higher medical costs and increased healthcare utilisation. There are indications that it also leads to higher absence from work. No conflicts of interest. No funding obtained


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 42 - 42
1 Dec 2021
Awadallah M Parker M Easey S Gurusamy K
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Abstract. BACKGROUND. The effectiveness of anti-embolic graduated compression stockings (GCSs) has recently been questioned. The aim of this study is to systematically review all the relevant randomised controlled trials published to date. PATIENTS AND METHODS. We systematically reviewed all the randomised controlled trials comparing anti-embolism stockings with no stockings. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL, Cochrane Musculoskeletal Injuries Group specialized register and the reference lists of articles as well as hand search results. Trials were independently assessed and data for the main outcome measures; deep vein thrombosis (DVT), pulmonary embolism and skin ulceration, were extracted by two reviewers. RESULTS. A total of 26 relevant RCTs involving 8279 participants were systematically reviewed. Theoccurrence of deep vein thrombosis was 306/4159(7.3%) with the stocking to 492/4120(11.9%) without the stockings (RR 0.49, 95% CI 0.39–0.62). The occurrence of pulmonary embolism was also reduced from 1.2% go 0.7% (95% 0.33–0.92). This initial finding was unsound due to the potential underreporting of negative studies and the subsequent changes to clinical practice. For the three large contemporary studies involving 5171 participants, these failed to show any statistically significant reduction in thrombosis, with DVT confirmed in 158(6.1%) participants in those allocated to stocking, as opposed to 171(6.6%) in the control group. CONCLUSION. The current recommendations regarding the use of GCSs need to be reconsidered, as their effectiveness at reducing the occurrence of post-operative DVT is minimal at best, based on the current evidence and clinical practices


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 116 - 116
1 Apr 2012
Pickard R Sharma A Reynolds J Nnadi C Lavy C Bowden G Wilson-MacDonald J Fairbank J
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A literature review of bone graft substitutes for spinal fusion was undertaken from peer reviewed journals to form a basis for guidelines on their clinical use. A PubMed search of peer reviewed journals between Jan 1960 and Dec 2009 for clinical trials of bone graft substitutes in spinal fusion was performed. Emphasis was placed on RCTs. Small and duplicated RCTs were excluded. If no RCTs were available the next best clinical evidence was assessed. Data were extracted for fusion rates and complications. Of 929 potential spinal fusion studies, 7 RCTs met the inclusion criteria for BMP-2, 3 for BMP-7, 2 for Tricalcium Phosphate and 1 for Tricalcium Phosphate/Hydroxyapatite (TCP/HA). No clinical RCTs were found for Demineralised Bone Matrix (DBM), Calcium Sulphate or Calcium Silicate. There is strong evidence that BMP-2 with TCP/HA achieves similar or higher spinal fusion rates than autograft alone. BMP-7 achieved similar results to autograft. 3 RCTs support the use of TCP or TCP/HA and autograft as a graft extender with similar results to autograft alone. The best clinical evidence to support the use of DBMs are case control studies. The osteoinductive potential of DBM appears to be very low however. There are no clinical studies to support the use of Calcium Silicate. The current literature supports the use of BMP-2 with HA/TCP as a graft substitute. TCP or HA/TCP with Autograft is supported as a graft extender. There is not enough clinical evidence to support other bone graft substitutes. This study did not require ethics approval and no financial support was received