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Bone & Joint Research
Vol. 4, Issue 7 | Pages 117 - 119
1 Jul 2015
Simpson AHRW


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 782 - 786
1 Jun 2012
Schwartz I Kandel L Sajina A Litinezki D Herman A Mattan Y

We investigated the extent to which improved balance relative to pain relief correlates with the success of total knee replacement (TKR). A total of 81 patients were recruited to the study: 16 men (19.8%) and 65 women (80.2%). Of these, 62 patients (10 men, 52 women) with a mean age of 73 (57 to 83) underwent static and dynamic assessment of balance pre-operatively and one year post-operatively. The parameters of balance were quantified using commercially available and validated equipment. Motor function and self-reported outcome were also assessed.

There was a significant improvement in dynamic balance (p < 0.001) one year after TKR, and better balance correlated with improved mobility, functional balance and increased health-related quality of life. As it seems that balance, and not only pain relief, influences the success of TKR, balance skills should be better addressed during the post-operative rehabilitation of patients who undergo TKR.


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 5 | Pages 855 - 855
1 Sep 1996
NOLAN PC


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 9 | Pages 1294 - 1299
1 Sep 2010
Ashby E Haddad FS O’Donnell E Wilson APR

As of April 2010 all NHS institutions in the United Kingdom are required to publish data on surgical site infection, but the method for collecting this has not been decided. We examined 7448 trauma and orthopaedic surgical wounds made in patients staying for at least two nights between 2000 and 2008 at our institution and calculated the rate of surgical site infection using three definitions: the US Centers for Disease Control, the United Kingdom Nosocomial Infection National Surveillance Scheme and the ASEPSIS system. On the same series of wounds, the infection rate with outpatient follow-up according to Centre for Disease Control was 15.45%, according to the UK Nosocomial infection surveillance was 11.32%, and according to ASEPSIS was 8.79%. These figures highlight the necessity for all institutions to use the same method for diagnosing surgical site infection.

If different methods are used, direct comparisons will be invalid and published rates of infection will be misleading.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 4 | Pages 466 - 470
1 Apr 2012
Malviya A Stafford GH Villar RN

The benefit of arthroscopy of the hip in the treatment of femoroacetabular impingement (FAI) in terms of quality of life (QoL) has not been reported. We prospectively collected data on 612 patients (257 women (42%) and 355 men (58%)) with a mean age at the time of surgery of 36.7 years (14 to 75) who underwent arthroscopy of the hip for FAI under the care of a single surgeon. The minimum follow-up was one year (mean 3.2 years (1 to 7)). The responses to the modified Harris hip score were translated using the Rosser Index Matrix in order to provide a QoL score. The mean QoL score increased from 0.946 (-1.486 to 0.995) to 0.974 (0.7 to 1) at one year after surgery (p < 0.001). The mean QoL score in men was significantly higher than in women, both before and one year after surgery (both p < 0.001). However, the mean change in the QoL score was not statistically different between men and women (0.02 (-0.21 to 0.27) and 0.04 (-0.16 to 0.87), respectively; p = 0.12). Linear regression analysis revealed that the significant predictors of a change in QoL score were pre-operative QoL score (p < 0.001) and gender (p = 0.04). The lower the pre-operative score, the higher the gain in QoL post-operatively (ρ = -0.66; p < 0.001). One year after surgery the QoL scores in the 612 patients had improved in 469 (76.6%), remained unchanged in 88 (14.4%) and had deteriorated in 55 (9.0%).


Bone & Joint Research
Vol. 1, Issue 5 | Pages 71 - 77
1 May 2012
Keurentjes JC Van Tol FR Fiocco M Schoones JW Nelissen RG

Objectives

We aimed first to summarise minimal clinically important differences (MCIDs) after total hip (THR) or knee replacement (TKR) in health-related quality of life (HRQoL), measured using the Short-Form 36 (SF-36). Secondly, we aimed to improve the precision of MCID estimates by means of meta-analysis.

Methods

We conducted a systematic review of English and non-English articles using MEDLINE, the Cochrane Controlled Trials Register (1960–2011), EMBASE (1991–2011), Web of Science, Academic Search Premier and Science Direct. Bibliographies of included studies were searched in order to find additional studies. Search terms included MCID or minimal clinically important change, THR or TKR and Short-Form 36. We included longitudinal studies that estimated MCID of SF-36 after THR or TKR.


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 8 | Pages 1220 - 1220
1 Nov 2004
PERVEZ H PARKER MJ


The Journal of Bone & Joint Surgery British Volume
Vol. 85-B, Issue 8 | Pages 1107 - 1113
1 Nov 2003
Dorotka R Schoechtner H Buchinger W

We compared the mortality and outcome of 182 patients with proximal fractures of the femur after immediate and delayed surgical treatment. Seventy-nine patients were operated upon within six hours of the fracture (group 1) and 103 patients were operated upon after this period of time (group 2).

At six months follow-up, group 1 had a significantly lower mortality rate. There was a good outcome in both groups with no differences in the outcome. Neither surgical nor anaesthetic factors appeared to have influenced mortality. The subdivision of groups revealed that patients operated on within 24 hours had a better outcome than those whose surgery was delayed.

Although there may have been a bias, as patients were not randomly assigned to immediate or delayed surgical treatment, the data suggest that early stabilisation may be associated with a lower mortality rate. Even with pre-clinical delays of more than six hours early treatment should still be attempted, as better results seem to be achieved after 24 hours compared to a later time in our patients.


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 3 | Pages 339 - 343
1 Apr 2002
van Bergayk AB Garbuz DS

We have undertaken a prospective evaluation of health-related quality-of-life outcomes in 26 consecutive patients undergoing periacetabular osteotomy with a minimum follow-up of 24 months (24 to 42). The Western Ontario-Macmaster (WOMAC) and Short Form 36 (SF-36) outcome measures were evaluated preoperatively and at follow-up. Secondary outcome measures included retrospective assessment of sports activity and satisfaction with the procedure.

Follow-up data were available for 22 patients (85%). A significant improvement in the pain (p < 0.0001) and function (p < 0.0001) scales of the WOMAC and the SF-36 physical score (p < 0.0001) was seen. The mean sports activity score improved from 1.9 to 4.4, with a very high mean satisfaction rating of 89.7/100.

A significant improvement in both global and disease-specific health outcomes can be expected after this operation, with a high rate of satisfaction and improvement in sporting activities.


Bone & Joint Research
Vol. 13, Issue 5 | Pages 201 - 213
1 May 2024
Hamoodi Z Gehringer CK Bull LM Hughes T Kearsley-Fleet L Sergeant JC Watts AC

Aims. The aims of this study were to identify and evaluate the current literature examining the prognostic factors which are associated with failure of total elbow arthroplasty (TEA). Methods. Electronic literature searches were conducted using MEDLINE, Embase, PubMed, and Cochrane. All studies reporting prognostic estimates for factors associated with the revision of a primary TEA were included. The risk of bias was assessed using the Quality In Prognosis Studies (QUIPS) tool, and the quality of evidence was assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. Due to low quality of the evidence and the heterogeneous nature of the studies, a narrative synthesis was used. Results. A total of 19 studies met the inclusion criteria, investigating 28 possible prognostic factors. Most QUIPS domains (84%) were rated as moderate to high risk of bias. The quality of the evidence was low or very low for all prognostic factors. In low-quality evidence, prognostic factors with consistent associations with failure of TEA in more than one study were: the sequelae of trauma leading to TEA, either independently or combined with acute trauma, and male sex. Several other studies investigating sex reported no association. The evidence for other factors was of very low quality and mostly involved exploratory studies. Conclusion. The current evidence investigating the prognostic factors associated with failure of TEA is of low or very low quality, and studies generally have a moderate to high risk of bias. Prognostic factors are subject to uncertainty, should be interpreted with caution, and are of little clinical value. Higher-quality evidence is required to determine robust prognostic factors for failure of TEA. Cite this article: Bone Joint Res 2024;13(5):201–213


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


Bone & Joint Open
Vol. 5, Issue 3 | Pages 218 - 226
15 Mar 2024
Voigt JD Potter BK Souza J Forsberg J Melton D Hsu JR Wilke B

Aims. Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Methods. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated. Results. For treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467. Conclusion. The use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness. Cite this article: Bone Jt Open 2024;5(3):218–226


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 795 - 800
1 Jul 2023
Parsons N Achten J Costa ML

Aims. To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial. Methods. The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded. Results. There was no evidence of a difference in patient-reported disability, health-related quality of life, or the need for further surgery between participants treated with either type of fixation at five years. Considering the combined results for all participants, there was no significant change in DRI scores after the first 12 months of follow-up (difference between 12 and 24 months, 3.3 (95% confidence interval -1.8 to 8.5); p = 0.203), with patients reporting around 20% disability at five years. Conclusion. This study shows that the moderate levels of disability and reduced quality of life reported by participants 12 months after a fracture of the distal tibia persist in the medium term, with little evidence of improvement after the first year. Cite this article: Bone Joint J 2023;105-B(7):795–800


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 656 - 661
1 Jul 2024
Bolbocean C Hattab Z O'Neill S Costa ML

Aims. Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. Methods. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively. Results. Our analysis revealed a complex landscape of responses to the use of a cemented hemiarthroplasty in the 12 months after surgery. There was heterogeneity of effects with regard to baseline characteristics, including age, pre-injury health status, and lifestyle factors such as alcohol consumption. This heterogeneity was greater at the one-month mark than at subsequent follow-up timepoints, with particular regard to subgroups based on age. However, for all subgroups, the effect estimates for quality of life lay within the confidence intervals derived from the analysis of all patients. Conclusion. The use of a cemented hemiarthroplasty is expected to increase health-related quality of life compared with modern uncemented hemiarthroplasty for all subgroups of patients aged > 60 years with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2024;106-B(7):656–661


Bone & Joint Open
Vol. 4, Issue 3 | Pages 158 - 167
10 Mar 2023
Landers S Hely R Hely A Harrison B Page RS Maister N Gwini SM Gill SD

Aims. This study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure. Methods. A total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests. Results. Overall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group. Conclusion. TAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made. Level of evidence: I. Cite this article: Bone Jt Open 2023;4(3):158–167


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1369 - 1371
1 Dec 2024
Tabu I Ivers R Costa ML

In the UK, multidisciplinary teamwork for patients with hip fracture has been shown to reduce mortality and improves health-related quality of life for patients, while also reducing hospital bed days and associated healthcare costs. However, despite rapidly increasing numbers of fragility fractures, multidisciplinary shared care is rare in low- and middle-income countries around the world. The HIPCARE trial will test the introduction of multidisciplinary care pathways in five low- and middle-income countries in South and Southeast Asia, with the aim to improve patients’ quality of life and reduce healthcare costs. Cite this article: Bone Joint J 2024;106-B(12):1369–1371


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 455 - 464
15 Mar 2023
de Joode SGCJ Meijer R Samijo S Heymans MJLF Chen N van Rhijn LW Schotanus MGM

Aims. Multiple secondary surgical procedures of the shoulder, such as soft-tissue releases, tendon transfers, and osteotomies, are described in brachial plexus birth palsy (BPBP) patients. The long-term functional outcomes of these procedures described in the literature are inconclusive. We aimed to analyze the literature looking for a consensus on treatment options. Methods. A systematic literature search in healthcare databases (PubMed, Embase, the Cochrane library, CINAHL, and Web of Science) was performed from January 2000 to July 2020, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The quality of the included studies was assessed with the Cochrane ROBINS-I risk of bias tool. Relevant trials studying BPBP with at least five years of follow-up and describing functional outcome were included. Results. Of 5,941 studies, 19 were included after full-text screening. A total of 15 surgical techniques were described. All studies described an improvement in active external rotation (range 12° to 128°). A decrease in range of motion and Mallet score after long-term (five to 30 years) follow-up compared to short-term follow-up was seen in most studies. Conclusion. The literature reveals that functional outcome increases after different secondary procedures, even in the long term. Due to the poor methodological quality of the included studies and the variations in indication for surgery and surgical techniques described, a consensus on the long-term functional outcome after secondary surgical procedures in BPBP patients cannot be made. Cite this article: Bone Joint J 2023;105-B(4):455–464


Bone & Joint Research
Vol. 12, Issue 8 | Pages 455 - 466
1 Aug 2023
Zhou H Chen C Hu H Jiang B Yin Y Zhang K Shen M Wu S Wang Z

Aims. Rotator cuff muscle atrophy and fatty infiltration affect the clinical outcomes of rotator cuff tear patients. However, there is no effective treatment for fatty infiltration at this time. High-intensity interval training (HIIT) helps to activate beige adipose tissue. The goal of this study was to test the role of HIIT in improving muscle quality in a rotator cuff tear model via the β3 adrenergic receptor (β3AR). Methods. Three-month-old C57BL/6 J mice underwent a unilateral rotator cuff injury procedure. Mice were forced to run on a treadmill with the HIIT programme during the first to sixth weeks or seventh to 12th weeks after tendon tear surgery. To study the role of β3AR, SR59230A, a selective β3AR antagonist, was administered to mice ten minutes before each exercise through intraperitoneal injection. Supraspinatus muscle, interscapular brown fat, and inguinal subcutaneous white fat were harvested at the end of the 12th week after tendon tear and analyzed biomechanically, histologically, and biochemically. Results. Histological analysis of supraspinatus muscle showed that HIIT improved muscle atrophy, fatty infiltration, and contractile force compared to the no exercise group. In the HIIT groups, supraspinatus muscle, interscapular brown fat, and inguinal subcutaneous white fat showed increased expression of tyrosine hydroxylase and uncoupling protein 1, and upregulated the β3AR thermogenesis pathway. However, the effect of HIIT was not present in mice injected with SR59230A, suggesting that HIIT affected muscles via β3AR. Conclusion. HIIT improved supraspinatus muscle quality and function after rotator cuff tears by activating systemic sympathetic nerve fibre near adipocytes and β3AR. Cite this article: Bone Joint Res 2023;12(8):455–466


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 711 - 716
1 Jun 2023
Ali MS Khattak M Metcalfe D Perry DC

Aims. This study aimed to evaluate the relationship between hip shape and mid-term function in Perthes’ disease. It also explored whether the modified three-group Stulberg classification can offer similar prognostic information to the five-group system. Methods. A total of 136 individuals aged 12 years or older who had Perthes’ disease in childhood completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility score (function), Nonarthritic Hip Score (NAHS) (function), EuroQol five-dimension five-level questionnaire (EQ-5D-5L) score (quality of life), and the numeric rating scale for pain (NRS). The Stulberg class of the participants’ hip radiographs were evaluated by three fellowship-trained paediatric orthopaedic surgeons. Hip shape and Stulberg class were compared to PROM scores. Results. A spherical hip was associated with the highest function and quality of life, and lowest pain. Conversely, aspherical hips exhibited the lowest functional scores and highest pain. The association between worsening Stulberg class (i.e. greater deviation from sphericity) and worse outcome persisted after adjustment for age and sex in relation to PROMIS (predicted mean difference -1.77 (95% confidence interval (CI) -2.70 to -0.83)), NAHS (-5.68 (95% CI -8.45 to -2.90)), and NRS (0.61 (95% CI 0.14 to 1.08)), but not EQ-5D-5L (-0.03 (95% CI -0.72 to 0.11)). Conclusion. Patient-reported outcomes identify lower function, quality of life, and higher pain in aspherical hips. The magnitude of symptoms deteriorated with time. Hip sphericity (i.e. the modified three-group classification of spherical, oval, and aspherical) appeared to offer similar levels of detail to the five-group Stulberg classification. Cite this article: Bone Joint J 2023;105-B(6):711–716


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1072 - 1080
4 Dec 2024
Tang M Lun KK Lewin AM Harris IA

Aims. Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Methods. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews. Results. We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT. Conclusion. There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs. Cite this article: Bone Jt Open 2024;5(12):1072–1080