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Bone & Joint Open
Vol. 6, Issue 2 | Pages 195 - 205
14 Feb 2025
Selim A Dass D Govilkar S Brown AJ Bonde S Burston B Thomas G

Aims

The conversion of previous hip fracture surgery to total hip arthroplasty (CTHA) can be surgically challenging with unpredictable outcomes; reported complication rates vary significantly. This study aimed to establish the medium-term survival and outcomes of CTHA performed following a previous hip fracture surgery.

Methods

All CTHAs performed at our tertiary orthopaedic institution between January 2008 and January 2020 following previous ipsilateral hip fracture surgery were included. Patients were followed up clinically using Oxford Hip Scores (OHS), and radiologically until death or revision surgery. Postoperative complications, radiological implant failure, and indications for revision surgery were reviewed.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 186 - 194
13 Feb 2025
Battaglia AG D'Apolito R Ding BTK Tonolini S Ramazzotti J Zagra L

Aims

Revision hip arthroplasty for femoral stem loosening remains challenging due to significant bone loss and deformities requiring specialized revision stems. The aim of this study was to evaluate the clinical and radiological outcomes, and survival, of a consecutive series of femoral revisions performed using a primary cementless stem with tapered geometry and rectangular cross-section at medium-term follow-up.

Methods

We retrospectively evaluated 113 patients (115 hips) with intraoperative Paprosky type I (n = 86) or II (n = 29) defects, who underwent femoral revision with Alloclassic Zweymüller SL stem for one-stage aseptic revision or two-stage septic revision from January 2011 to December 2020. The mean follow-up was 77.9 months (SD 33.8). Nine patients were lost to follow-up (deceased or not available), leaving 104 patients (106 hips) for the clinical and radiological analysis. Clinical assessment was performed with Harris Hip Score (HHS) and visual analogue scale (VAS) before surgery and at final follow-up.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 178 - 185
11 Feb 2025
Gallant A Vandekerckhove P Beckers L De Smet A Depuydt C Victor J Hardeman F

Aims

Valgus subsidence of uncemented tibial components following medial unicompartmental knee arthroplasty (UKA) poses a challenge in the early postoperative phase, necessitating a comprehensive understanding of its prevalence, risk factors, and impact on patient outcomes.

Methods

This prospective multicentre study analyzed 97 knees from 90 patients undergoing UKA across four participating hospitals. A standardized surgical technique was employed uniformly by all participating surgeons. Postoperative evaluations were conducted preoperatively, and one day, four weeks, three months, and one year postoperative, encompassing weightbearing radiographs, bone mineral density assessments, and clinical outcome reports using the Forgotten Joint Score and Oxford Knee Score. Statistical analyses, including non-parametric correlation analysis using the Kendall correlation coefficient and Mann-Whitney U test, were performed to explore associations between subsidence and various patient-related or radiological parameters.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 164 - 177
10 Feb 2025
Clement ND Scott CEH Macpherson GJ Simpson PM Leitch G Patton JT

Aims

Unicompartmental knee arthroplasty (UKA) is associated with an accelerated recovery, improved functional outcomes, and retention of anatomical knee kinematics when compared to manual total knee arthroplasty (mTKA). UKA is not universally employed by all surgeons as there is a higher revision risk when compared to mTKA. Robotic arm-assisted (ra) UKA enables the surgeon to position the prosthesis more accurately when compared to manual UKA, and is associated with improved functional outcomes and a lower early revision risk. Non-randomized data suggests that, when compared to mTKA, raUKA has a clinically meaningful greater functional benefit. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of raUKA compared to mTKA for individuals with isolated medial compartment osteoarthritis (OA).

Methods

The total versus robotic-assisted unicompartmental knee arthroplasty (TRAKER) trial is a patient- and assessor-blinded, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary knee arthroplasty for primary medial compartment OA at a single NHS hospital (ClinicalTrials.gov NCT05290818). Participants will be randomly allocated on a 1:2 basis to either raUKA or mTKA, respectively. The primary analysis will compare the Oxford Knee Score (OKS) six months after surgery. Secondary outcomes measured at three, six, and 12 months include the OKS, Forgotten Joint Score, patient expectations, EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (EQ-VAS), patient satisfaction, range of motion, postoperative complications, need for further surgery, resource use, and financial costs. Cost-effectiveness will be measured over a ten-year time span. A total of 159 patients will be randomized (n = 53 raUKA vs n = 106 mTKA) to obtain 80% power to detect a five-point difference in OKS between the groups six months after surgery.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 155 - 163
8 Feb 2025
Konishi T Hamai S Kawahara S Hara D Sato T Motomura G Utsunomiya T Nakashima Y

Aims. This study aimed to investigate whether the use of CT-based navigation enhances: 1) the accuracy of cup placement; and 2) the achievement rate of required range of motion (ROM). Additionally, we investigated the impact of using a large femoral head and dual-mobility liner on the achievement rates. Methods. This retrospective study analyzed 60 manual and 51 CT-based navigated primary total hip arthroplasties performed at a single facility. Postoperative CT scans and CT-based simulation software were employed to measure the cup orientation and to simulate the ROM. We compared the absolute errors for radiological inclination (RI) and radiological anteversion (RA) between the two groups. We also examined whether the simulated ROM met the required ROM criteria, defined as flexion > 110°, internal rotation > 30°, extension > 30°, and external rotation > 30°. Furthermore, we performed simulations with 36 mm femoral head and dual-mobility liner. Results. The absolute errors of RI and RA from the preoperative plan were significantly smaller in the CT-based navigation group (3.7° (SD 3.5°) vs 5.1° (SD 3.5°); p = 0.022, and 3.9° (SD 3.5°) vs 6.8° (SD 5.0°); p = 0.001, respectively). The proportion of cases achieving the required ROM in all directions was significantly higher in the CT-based navigation group (42% vs 63%; p = 0.036). The achievement rates of the required ROM were significantly higher with the use of a 36 mm ball or dual-mobility liner compared to the use of a 32 mm ball (65% vs 51%; p = 0.040 and 77% vs 51%; p ≤ 0.001, respectively). Conclusion. CT-based navigation enhanced required ROM achievement rates by > 20%, regardless of the ball diameter. The improved accuracy of cup placement through CT-based navigation likely contributed to the enhancement. Furthermore, the use of large femoral heads and dual-mobility liners also improved the required ROM achievement rates. In cases with a high risk of dislocation, use of these devices is preferred. Cite this article: Bone Jt Open 2025;6(2):155–163


Bone & Joint Open
Vol. 6, Issue 2 | Pages 147 - 154
7 Feb 2025
Clement ND Qaddoura B Coppola A Akram N Pendyala S Jones S Afzal I Kader DF

Aims

Control of acute pain following knee arthroplasty (KA) with a perioperative peripheral nerve block (PNB) may improve functional outcomes and reduce the risk of chronic postoperative knee pain (CPKP). The aims of this study were to assess whether a PNB influences patient-reported outcomes and risk of CPKP at one year following KA.

Methods

A retrospective study was conducted over a two-year period and included 3,338 patients who underwent KA, of whom 1,434 (43.0%) had a lower limb PNB. A total of 2,588 patients (77.6%) completed and returned their one-year follow-up questionnaire. The Oxford Knee Score (OKS) and pain component (OKS-PS), EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (VAS) were collected preoperatively and at one year postoperatively. Patient satisfaction was also recorded at one year. The OKS-PS was used to define CPKP at one year.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 135 - 146
6 Feb 2025
Sherratt FC Swaby L Walker K Jayasuriya R Campbell L Mills AJ Gardner AC Perry DC Cole A Young B

Aims

The Bracing Adolescent Idiopathic Scoliosis (BASIS) study is a randomized controlled non-inferiority pragmatic trial of ‘full-time bracing’ (FTB) compared to ‘night-time bracing’ (NTB) for the treatment of adolescent idiopathic scoliosis (AIS). We anticipated that recruiting patients to BASIS would be challenging, as it is a paediatric trial comparing two markedly different bracing pathways. No previous studies have compared the experiences of AIS patients treated with FTB to those treated with NTB. This qualitative study was embedded in BASIS to explore families’ perspectives of BASIS, to inform trial communication, and to identify strategies to support patients treated in a brace.

Methods

Semi-structured interviews were conducted with parents (n = 26) and young people (n = 21) who had been invited to participate in BASIS at ten of the 22 UK paediatric spine services in hospitals recruiting to BASIS. Audio-recorded interviews were transcribed and analyzed thematically.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 126 - 134
4 Feb 2025
Schneller T Kraus M Schätz J Moroder P Scheibel M Lazaridou A

Aims

Machine learning (ML) holds significant promise in optimizing various aspects of total shoulder arthroplasty (TSA), potentially improving patient outcomes and enhancing surgical decision-making. The aim of this systematic review was to identify ML algorithms and evaluate their effectiveness, including those for predicting clinical outcomes and those used in image analysis.

Methods

We searched the PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases for studies applying ML algorithms in TSA. The analysis focused on dataset characteristics, relevant subspecialties, specific ML algorithms used, and their performance outcomes.


Bone & Joint Open
Vol. 6, Issue 2 | Pages 119 - 125
3 Feb 2025
Husum H Hellfritzsch MB Maimburg RD Møller-Madsen B Henriksen M Lapitskaya N Kold S Rahbek O

Aims

To establish cut-off values for lateral pubofemoral distance (PFD) measurements for detecting hip dysplasia in early (four days) and standard care (six weeks) screening for developmental dysplasia of the hip (DDH).

Methods

All newborns, during a one-year period (October 2021 to October 2022), were offered a PFD ultrasound (US) examination in addition to the existing screening programme for DDH. Newborns who were referred for standard care hip US, suspected for DDH, received a secondary PFD US examination in conjunction with the standard care Graf/Harcke hip US examination. Receiver operating characteristic curves and empirically optimal cut-off values were calculated with a true positive defined as a Graf type ≥ IIc hip.


Aims

The primary aim of this study is to compare mobility status of patients receiving oral oxycodone with those receiving subcutaneous alfentanil as analgesic methods prior to mobilization to help physiotherapy compliance after hip fracture surgery. The secondary aims are to assess postoperative pain, health-related quality of life, in-hospital length of stay, total use of analgesia over postoperative days 1 and 2 (POD 1 and POD 2), complication rates within 30 days, and 30-day mortality rates.

Methods

A single-centre, prospective cohort study of 64 patients will be undertaken. Patients undergoing surgery for femoral neck fractures at the study centre will be recruited. Patients with a hip fracture meeting the inclusion/exclusion criteria will be enrolled on admission. Patients who have been administered oral oxycodone will be compared to those prescribed alfentanil for pain prior to mobilization with physiotherapists on POD 1 and POD 2. Which drug a patient receives is reliant of the prescriptions given by the medical team, and in current practice this varies at approximately 50:50. Mobilization will be defined as the ability to stand on and weightbear both feet with or without assistance.


Aims

The Peri-Implant and PeriProsthetic Survival AnalysiS (PIPPAS) study aimed to investigate the risk factors for one-year mortality of femoral peri-implant fractures (FPIFs).

Methods

This prospective, multicentre, observational study involved 440 FPIF patients with a minimum one-year follow-up. Data on demographics, clinical features, fracture characteristics, management, and mortality rates were collected and analyzed using both univariate and multivariate analyses. FPIF patients were elderly (median age 87 years (IQR 81 to 92)), mostly female (82.5%, n = 363), and frail: median clinical frailty scale 6 (IQR 4 to 7), median Pfeiffer 4 (1 to 7), median age-adjusted Charlson Comorbidity Index (CCI) 6 (IQR 5 to 7), and 58.9% (n = 250) were American Society of Anesthesiologists grade III.


Bone & Joint Open
Vol. 6, Issue 1 | Pages 35 - 42
8 Jan 2025
Fischer M Nonnenmacher L Hofer A Zimmerer A Nitsch A Großjohann R Erdmann S Wassilew GI

Aims. Periacetabular osteotomy (PAO) is well established for acetabular reorientation and has shown successful improvement in patient-reported outcome measures (PROMs). Nevertheless, studies focusing on postoperative outcomes related to patient individual factors are still underrepresented. Therefore, this study aimed to analyze the functional outcome and activity level in relation to patient sex with a minimum follow-up of two years after PAO for mild to severe hip dysplasia. Methods. A single-centre study was conducted, enrolling patients undergoing PAO and completing a preoperative and postoperative radiological and clinical outcome assessment. The PROMs were assessed using the modified Harris Hip Score (mHHS), the Hip disability and Osteoarthritis Outcome Score (HOOS) with the subscales for pain, sport, activities of daily living (ADL), and quality of life (QoL), and the University of California, Los Angeles (UCLA) activity score. Kendall’s tau were calculated for correlation analyses. Results. In total, 145 patients (28 male, 117 female) were included. The PROMs improved significantly across males and females at the latest follow-up. Female patients had significantly lower preoperative PROMs: mHHS (47 vs 57.4; p = 0.002); HOOS pain (44.9 vs 60; p = 0.003), sport (47 vs 57.4; p = 0.002), ADL (58.9 vs 69.3; p = 0.032), and QoL (26.8 vs 39.3; p = 0.009); and UCLA (5.6 vs 6.7, p = 0.042) scores. Males showed higher postoperative UCLA scores (7.5 vs 6.7; p = 0.03). Kendall’s tau showed significant negative correlation between BMI and UCLA scores in females and males (-0.21 to -0.29; p = 0.002/0.048), while BMI and HOOS sport (-0.16; p = 0.015) and ADL (-0.2; p = 0.003), as well as QoL (-0.14; p = 0.031) and preoperative acetabular inclination (-0.13; p = 0.049) were only significantly negatively correlated in females. Conclusion. Patient sex affects PROMs before and after PAO. Female patients experience higher improvement in hip function and activity level, due to poorer preoperative PROMs than males. Thus, these data are particularly interesting in providing preoperative guidance regarding postoperative outcome expectations. Cite this article: Bone Jt Open 2024;6(1):35–42


Bone & Joint Open
Vol. 6, Issue 1 | Pages 21 - 25
4 Jan 2025
Craven J O’Malley O Perry DC

Aims

This study aims to define a set of family-centred core outcomes for infants undergoing brace treatment to facilitate consistent reporting for future high-quality research.

Methods

Family-centred outcomes will be identified through a literature review and a scoping survey involving key stakeholders, including parents, healthcare professionals, and researchers. These outcomes will then be rated for their perceived importance in a two-stage modified Delphi process with the same stakeholders. Finally, a consensus meeting will be held to establish the final core outcome set (COS).


Bone & Joint Open
Vol. 6, Issue 1 | Pages 12 - 20
3 Jan 2025
Chan KCA Cheung A Chan P Luk MH Chiu KY Fu H

Aims

Around the world, the emergence of robotic technology has improved surgical precision and accuracy in total knee arthroplasty (TKA). This territory-wide study compares the results of various robotic TKA (R-TKA) systems with those of conventional TKA (C-TKA) and computer-navigated TKA (N-TKA).

Methods

This is a retrospective study utilizing territory-wide data from the Clinical Data Analysis and Reporting System (CDARS). All patients who underwent primary TKA in all 47 public hospitals in Hong Kong between January 2021 and December 2023 were analyzed. Primary outcomes were the percentage use of various robotic and navigation platforms. Secondary outcomes were: 1) mean length of stay (LOS); 2) 30-day emergency department (ED) attendance rate; 3) 90-day ED attendance rate; 4) 90-day reoperation rate; 5) 90-day mortality rate; and 6) surgical time.


Bone & Joint Open
Vol. 6, Issue 1 | Pages 3 - 11
1 Jan 2025
Shimizu A Murakami S Tamai T Haga Y Kutsuna T Kinoshita T Takao M

Aims

Excellent outcomes have been reported following CT-based robotic arm-assisted total hip arthroplasty (rTHA) compared with manual THA; however, its superiority over CT-based navigation THA (nTHA) remains unclear. This study aimed to determine whether a CT-based robotic arm-assisted system helps surgeons perform accurate cup placement, minimizes leg length, and offsets discrepancies more than a CT-based navigation system.

Methods

We studied 60 hips from 54 patients who underwent rTHA between April 2021 and August 2023, and 45 hips from 44 patients who underwent nTHA between January 2020 and March 2021 with the same target cup orientation at the Department of Orthopedic Surgery at Ozu Memorial Hospital, Japan. After propensity score matching, each group had 37 hips. Postoperative acetabular component position and orientation were measured using the planning module of the CT-based navigation system. Postoperative leg length and offset discrepancies were evaluated using postoperative CT in patients who have unilateral hip osteoarthritis.


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1123 - 1129
20 Dec 2024
Manara JR Nixon M Tippett B Pretty W Collopy D Clark GW

Aims. Unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) have both been shown to be effective treatments for osteoarthritis (OA) of the knee. Many studies have compared the outcomes of the two treatments, but less so with the use of robotics, or individualized TKA alignment techniques. Functional alignment (FA) is a novel technique for performing a TKA and shares many principles with UKA. Our aim was to compare outcomes from a case-matched series of robotic-assisted UKAs and robotic-assisted TKAs performed using FA. Methods. From a prospectively collected database between April 2015 and December 2019, patients who underwent a robotic-assisted medial UKA (RA-UKA) were case-matched with patients who had undergone a FA robotic-assisted TKA (RA-TKA) during the same time period. Patients were matched for preoperative BMI, sex, age, and Forgotten Joint Score (FJS). A total of 101 matched pairs were eligible for final review. Postoperatively the groups were then compared for differences in patient-reported outcome measures (PROMs), range of motion (ROM), ability to ascend and descend stairs, and ability to kneel. Results. Both groups had significant improvements in mean FJS (65.1 points in the TKA group and 65.3 points in the UKA group) and mean Oxford Knee Score (OKS) (20 points in the TKA group and 18.2 in the UKA group) two years following surgery. The UKA group had superior outcomes at three months in the OKS and at one year in ROM (5°), ability to kneel (0.5 points on OKS question), and ascend (1.3 points on OKS question) and descend stairs (0.8 points on OKS question), but these were not greater than the minimal clinically important difference. There were no differences seen in FJS or OKS at one year postoperatively. There were no statistically significant differences between the groups at 24 months in all the variables assessed. Conclusion. FA-RATKA and RA-UKA are both successful treatments for medial compartmental knee arthritis in this study. The UKA group showed a quicker recovery, but this study demonstrated equivalent two-year outcomes in all outcomes measured including stair ascent and descent, and kneeling. Cite this article: Bone Jt Open 2024;5(12):1123–1129


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1108 - 1113
18 Dec 2024
Prakash R Nasser A Sharma A Eastwood D Reed M Agrawal Y

Aims. Arthroplasty has been shown to generate the most waste among all orthopaedic subspecialties, and it is estimated that hip and knee arthroplasty generate in excess of three million kg of waste annually in the UK. Infectious waste generates up to ten times more CO2 compared with recycled waste, and previous studies have shown that over 90% of waste in the infectious stream is misallocated. We assessed the effect of real-time waste segregation by an unscrubbed team member on waste generation in knee and hip arthroplasty cases, and compared this with a simple educational intervention during the ‘team brief’ at the start of the operating list across two sites. Methods. Waste was categorized into five categories: infectious, general, recycling, sharps, and linens. Each category was weighed at the end of each case using a digital weighing scale. At Site A (a tertiary orthopaedic hospital), pre-intervention data were collected for 16 total knee arthroplasy (TKA) and 15 total hip arthroplasty (THA) cases. Subsequently, for ten TKA and ten THA cases, an unscrubbed team member actively segregated waste in real-time into the correct streams. At Site B (a district general hospital), both pre- and post-intervention groups included ten TKA and ten THA cases. The intervention included reminding staff during the ‘team brief’ to segregate waste correctly. Results. Active real-time waste segregation reduced infectious waste by a mean of 2.51 kg (95% CI 1.492 to 3.542) in TKA, and 1.83 kg in THA cases (p = 0.004). Educational intervention reduced infectious waste by a mean of 3.52 kg in TKA and 2.09 kg in THA cases (p = 0.026). Total waste was significantly reduced in both groups post-intervention for TKA cases. Conclusion. Simple educational measures alone can significantly reduce the amount of infectious waste. Extrapolated nationally, our results would yield a reduction of approximately 315,004 kg to 594,577 kg of CO2 annually, which equates to 70 to 132 gasoline-powered passenger vehicles driven for a year. Cite this article: Bone Jt Open 2024;5(12):1119–1124


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1101 - 1107
11 Dec 2024
Haas-Lützenberger EM Emelianova I Bader MC Mert S Moellhoff N Demmer W Berger U Giunta R

Aims. In the treatment of basal thumb osteoarthritis (OA), intra-articular autologous fat transplantation has become of great interest within recent years as a minimally invasive and effective alternative to surgical intervention with regard to pain reduction. This study aims to assess its long-term effectiveness. Methods. Patients diagnosed with stage one to three OA received a single intra-articular autologous fat transplantation. Fat tissue was harvested from the abdomen and injected into the trapeziometacarpal (TMC) joint under radiological guidance, followed by one week of immobilization. Patients with a minimum three-year post-procedure period were assessed for pain level (numerical rating scale), quality of life (Mental Health Quotient (MHQ)), the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH)), and grip and pinch strength, as well as their overall impression of the treatment. Wilcoxon tests compared data from pre-intervention, and at one and three years post-intervention. Results. Out of 136 treated joints, the study involved 87 patients (37 patients were loss to follow-up, and 12 patients (9%) who underwent resection arthroplasty) with a median follow-up of 4.9 years (IQR 5.4 to 5.9). Pain, both at rest and during stress, significantly improved at one year and remained stable through three years. Sex, age, and stage of disease were not associated with postoperative pain levels. Patient-reported outcome measures for QuickDASH and MHQ improved up to at least three years post-treatment. Patients reported high satisfaction and willingness to recommend the procedure. Grip and pinch strength did not significantly change over time. Conclusion. The data show that autologous fat transfer has a longer-lasting effect in two-thirds of re-examined patients. If patients had an initial positive response, the pain-reducing effect lasted for at least three years. Therefore, this minimally invasive approach can offer a valuable treatment alternative for basal thumb OA


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1092 - 1100
8 Dec 2024
Fraser E Spence S Farhan-Alanie OM Doonan J Mahendra A Gupta S

Aims

Limb salvage surgery (LSS) is the primary treatment option for primary bone malignancy. It involves the removal of bone and tissue, followed by reconstruction with endoprosthetic replacements (EPRs) to prevent amputation. Trabecular metal (TM) collars have been developed to encourage bone ingrowth (osseointegration (OI)) into EPRs. The primary aim of this study was to assess whether OI occurs when TM collars are used in EPRs for tumour.

Methods

A total of 124 patients from July 2010 to August 2021 who underwent an EPR for tumour under the West of Scotland orthopaedic oncology team were identified. Overall, 81 patients (65%) met the inclusion criteria, and two consultants independently analyzed radiographs at three and 12 months, as well as the last radiograph, using a modified version of the Stanford Radiological Assessment System.


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.