Aims. The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment. Results. The offer of a soft bandage significantly reduced cost per patient (saving £12.55 (95% confidence interval (CI) -£5.30 to £19.80)) while QALYs were similar (QALY difference between groups: 0.0013 (95% CI -0.0004 to 0.003)). The high probability (95%) that offering a bandage is a cost-effective option was consistent when examining the data in a range of sensitivity analyses. Conclusion. In addition to the known clinical equivalence, this study found that the offer of a bandage reduced cost compared with rigid immobilization among children with a torus fracture of the distal radius. While the cost saving was small for each patient, the high frequency of these injuries indicates a significant saving across the healthcare system. Cite this article:
Aims. Histology is widely used for diagnosis of persistent infection during reimplantation in two-stage revision hip and knee arthroplasty, although data on its utility remain scarce. Therefore, this study aims to assess the predictive value of permanent sections at reimplantation in relation to reinfection risk, and to compare results of permanent and frozen sections. Methods. We retrospectively collected data from 226 patients (90 hips, 136 knees) with periprosthetic joint infection who underwent two-stage revision between August 2011 and September 2021, with a minimum follow-up of one year. Histology was assessed via the SLIM classification. First, we analyzed whether patients with positive permanent sections at reimplantation had higher reinfection rates than patients with negative histology. Further, we compared permanent and frozen section results, and assessed the influence of anatomical regions (knee versus hip), low- versus high-grade infections, as well as first revision versus multiple prior revisions on the histological result at reimplantation. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), chi-squared tests, and Kaplan-Meier estimates were calculated. Results. Overall, the reinfection rate was 18%. A total of 14 out of 82 patients (17%) with positive permanent sections at reimplantation experienced reinfection, compared to 26 of 144 patients (18%) with negative results (p = 0.996). Neither permanent sections nor fresh frozen sections were significantly associated with reinfection, with a sensitivity of 0.35, specificity of 0.63, PPV of 0.17, NPV of 0.81, and accuracy of 58%. Histology was not significantly associated with reinfection or survival time for any of the analyzed sub-groups. Permanent and frozen section results were in agreement for 91% of cases. Conclusion. Permanent and fresh frozen sections at reimplantation in two-stage revision do not serve as a reliable predictor for reinfection. Cite this article:
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:
Aims. Perthes' disease (PD) is a relatively rare syndrome of idiopathic osteonecrosis of the proximal femoral epiphysis. Treatment for Perthes' disease is controversial due to the many options available, with no clear superiority of one treatment over another. Despite having few evidence-based approaches, many patients with Perthes' disease are managed surgically. Positive outcome reporting, defined as reporting a study variable producing statistically significant positive (beneficial) results, is a phenomenon that can be considered a proxy for the strength of science. This study aims to conduct a systematic literature review with the hypothesis that positive outcome reporting is frequent in studies on the treatment of Perthes' disease. Methods. We conducted a systematic review of all available abstracts associated with manuscripts in English or with English translation between January 2000 and December 2021, dealing with the treatment of Perthes' disease. Data collection included various study characteristics, surgical versus non-surgical management, treatment modality, mean follow-up time, analysis methods, and clinical recommendations. Results. Our study included 130 manuscripts. Overall, 110 (85%) reported positive (beneficial) results, three (2%) reported negative results, and 17 (13%) reported no significant difference. Despite only 10/130 studies (8%) having a testable hypothesis, 71 (55%) recommended the use of their studied treatment methods for the patients, five (4%) made recommendations against the use of the studied treatment modality, and 54 (42%) did not make any recommendations. Conclusion. The overall rate for positive outcomes among included manuscripts regarding different treatment methods for Perthes' disease (85%) is higher than the 74% positive outcome rate found among studies for other surgically treated disorders and significantly higher than most scientific literature. Despite the lack of testable hypotheses, most manuscripts recommended their studied treatment method as a successful option for managing patients solely based on the reporting of retrospective data. Cite this article:
Aims. Fixation techniques used in the treatment of slipped capital femoral epiphysis (SCFE) that allow continued growth of the femoral neck, rather than inducing epiphyseal fusion in situ, have the advantage of allowing remodelling of the deformity. The aims of this study were threefold: to assess whether the Free-Gliding (FG) SCFE screw prevents further slip; to establish whether, in practice, it enables lengthening and gliding; and to determine whether the age of the patient influences the extent of glide. Methods. All patients with SCFE who underwent fixation using FG SCFE screws after its introduction at our institution, with minimum three years’ follow-up, were reviewed retrospectively as part of ongoing governance. All pre- and postoperative radiographs were evaluated. The demographics of the patients, the grade of slip, the extent of lengthening of the barrel of the screw and the restoration of Klein’s line were recorded. Subanalysis was performed according to sex and age. Results. A total of 19 hips in 13 patients were included. The mean age of the patients at the time of surgery was 11.5 years (9 to 13) and the mean follow-up was 63 months (45 to 83). A total of 13 FG SCFE screws were used for the fixation of mild or moderate SCFE, with six contralateral prophylactic fixations. No hip with SCFE showed a further slip after fixation and there were no complications. Lengthening occurred in 15 hips (79%), with a mean lengthening of the barrel of 6.8 mm (2.5 to 13.6) at final follow-up. Remodelling occurred in all hips with lengthening of the barrel. There was statistically more lengthening in patients who were aged < 12 years, regardless of sex (p = 0.002). Conclusion. The FG SCFE screw is effective in preventing further slip in patients with SCFE. Lengthening of the barrel occurred in most hips, and thus allowed remodelling. This was most marked in younger children, regardless of sex. Based on this study, this device should be considered for use in patients with SCFE aged < 12 years instead of standard pinning in situ. Cite this article:
Aims. When a total ankle arthroplasty (TAA) fails, it can be converted to a fusion or a revision arthroplasty. Despite the increasing numbers of TAAs being undertaken, there is little information in the literature about the management of patients undergoing fusion following a failed TAA. The primary aim of this study was to analyze the survival of fusions following a failed TAA using a large dataset from the National Joint Registry (NJR). Methods. A data linkage study combined NJR and NHS Digital data. Failure of a TAA was defined as a fusion, revision to a further TAA, or amputation. Life tables and Kaplan-Meier graphs were used to record survival. Cox proportional hazards regression models were fitted to compare the rates of failure. Results. A total of 131 patients underwent fusion as a salvage procedure following TAA. Their mean age was 65.7 years (SD 10.6) and 73 (55.7%) were male. The mean follow-up was 47.5 months (SD 27.2). The mean time between TAA and fusion was 5.3 years (SD 2.7). Overall, 32 (24.4%) underwent reoperations other than revision and 29 (22.1%) failed. Of these 24 (18.3%) underwent revision of the fusion and five (3.8%) had a below-knee amputation. No patients underwent conversion to a further TAA. Failure usually occurred in the first three postoperative years with one-year survival of fusion being 96.0% (95% confidence interval (CI) 90.7 to 98.3) and three-year survival in 69 patients being 77.5% (95% CI 68.3 to 84.4). Conclusion. Salvage fusion after a failed TAA shows moderate rates of failure and reoperations. Nearly 25% of patients required revision within three years. This study is an extension of studies using the same methodology reporting the failure rates and risk factors for failure, which have recently been published, and also one reporting the outcome of revision TAA for a failed primary TAA, using the same methodology, which will shortly be published. Cite this article:
Aims. This study aims to determine difference in annual rate of early-onset (≤ 90 days) deep surgical site infection (SSI) following primary total knee arthroplasty (TKA) for osteoarthritis, and to identify risk factors that may be associated with infection. Methods. This is a retrospective population-based cohort study using prospectively collected patient-level data between 1 January 2013 and 1 March 2020. The diagnosis of deep SSI was defined as per the Centers for Disease Control/National Healthcare Safety Network criteria. The Mann-Kendall Trend test was used to detect monotonic trends in annual rates of early-onset deep SSI over time. Multiple logistic regression was used to analyze the effect of different patient, surgical, and healthcare setting factors on the risk of developing a deep SSI within 90 days from surgery for patients with complete data. We also report 90-day mortality. Results. A total of 39,038 patients underwent primary TKA for osteoarthritis during the study period. Of these, 275 patients developed a deep SSI within 90 days of surgery, representing a cumulative incidence of 0.7%. The annual infection rate did not significantly decrease over the seven-year study period (p = 0.162). Overall, 13,885 (35.5%) cases were excluded from the risk analysis due to missing data. Risk factors associated with early-onset deep SSI included male sex, American Society of Anesthesiologists grade ≥ 3, blood transfusion, acute length of stay, and surgeon volume < 30 TKAs/year. Early-onset deep SSI was not associated with increased 90-day mortality. Conclusion. This study establishes a reliable baseline infection rate for early-onset deep SSI after TKA for osteoarthritis using robust Infection Prevention and Control surveillance data, and identifies several potentially modifiable risk factors. Cite this article:
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Aims. Distal femoral osteotomies (DFOs) are commonly used for the correction of valgus deformities and lateral compartment osteoarthritis. However, the impact of a DFO on subsequent total knee arthroplasty (TKA) function remains a subject of debate. Therefore, the purpose of this study was to determine the effect of a unilateral DFO on subsequent TKA function in patients with bilateral TKAs, using the contralateral knee as a self-matched control group. Methods. The inclusion criteria consisted of patients who underwent simultaneous or staged bilateral TKA after prior unilateral DFO between 1972 and 2023. The type of osteotomy performed, osteotomy hardware fixation, implanted TKA components, and revision rates were recorded. Postoperative outcomes including the Forgotten Joint Score-12 (FJS-12), Tegner Activity Scale score, and subjective knee preference were also obtained at final follow-up. Results. A total of 21 patients underwent bilateral TKA following unilateral DFO and were followed for a mean of 31.5 years (SD 11.1; 20.2 to 74.2) after DFO. The mean time from DFO to TKA conversion was 13.1 years (SD 9.7) with 13 (61.9%) of DFO knees converting to TKA more than ten years after DFO. There was no difference in arthroplasty implant systems employed in both the DFO-TKA and TKA-only knees (p > 0.999). At final follow-up, the mean FJS-12 of the DFO-TKA knee was 62.7 (SD 36.6), while for the TKA-only knee it was 65.6 (SD 34.7) (p = 0.328). In all, 80% of patients had no subjective knee preference or preferred their DFO-TKA knee. Three DFO-TKA knees and two TKA-only knees underwent subsequent revision following index arthroplasty at a mean of 12.8 years (SD 6.9) and 8.5 years (SD 3.8), respectively (p > 0.999). Conclusion. In this self-matched study, DFOs did not affect subsequent TKA function as clinical outcomes, subjective knee preference, and revision rates were similar in both the DFO-TKA and TKA-only knees at mean 32-year follow-up. Cite this article:
Aims. The aim of this study was to report the long-term follow-up of cemented short Exeter femoral components when used in primary total hip arthroplasty (THA). Methods. We included all primary 394 THAs with a cemented short Exeter femoral component (≤ 125 mm) used in our tertiary referral centre between October 1993 and December 2021. A total of 83 patients (21%) were male. The median age of the patients at the time of surgery was 42 years (interquartile range (IQR) 30 to 55). The main indication for THA was a childhood hip disease (202; 51%). The median follow-up was 6.7 years (IQR 3.1 to 11.0). Kaplan-Meier survival analyses were performed to determine the rates of survival with femoral revision for any indication, for septic loosening, for fracture of the femoral component and for aseptic loosening as endpoints. The indications for revision were evaluated. Fractures of the femoral component were described in detail. Results. The 20-year rate of survival was 85.4% (95% confidence interval (CI) 73.9 to 92.0) with revision for any indication, 96.2% (95% CI 90.5 to 98.5) with revision for septic loosening and 92.7% (95% CI 78.5 to 97.6) with revision for fracture of the femoral component. No femoral components were revised for aseptic loosening. There were 21 revisions of the femoral component; most (seven) as part of a two-stage management of infection. Fracture of the femoral component occurred in four THAs (1.0%) at 6.6, 11.6, 16.5, and 18.2 years of follow-up, respectively. Three of these were transverse fractures and occurred at the level of the lesser trochanter. In one THA, there was a fracture of the neck of the component. Conclusion. THAs using cemented short Exeter femoral components showed acceptable rates of survival of the femoral component at long-term follow-up, in this young cohort of patients. Although fracture is a rare complication of these components, surgeons should be aware of their incidence and possible risk factors. Cite this article:
Aims. To assess the alterations in cell-specific DNA methylation associated with chondroitin sulphate response using peripheral blood collected from Kashin-Beck disease (KBD) patients before initiation of chondroitin sulphate treatment. Methods. Peripheral blood samples were collected from KBD patients at baseline of chondroitin sulphate treatment. Methylation profiles were generated using reduced representation bisulphite sequencing (RRBS) from peripheral blood. Differentially methylated regions (DMRs) were identified using MethylKit, while DMR-related genes were defined as those annotated to the gene body or 2.2-kilobase upstream regions of DMRs. Selected DMR-related genes were further validated by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to assess expression levels. Tensor composition analysis was performed to identify cell-specific differential DNA methylation from bulk tissue. Results. This study revealed 21,060 hypermethylated and 44,472 hypomethylated DMRs, and 13,194 hypermethylated and 22,448 hypomethylated CpG islands for differential global methylation for chondroitin sulphate treatment response. A total of 12,666 DMR-related genes containing DMRs were identified in their promoter regions, such as CHL1 (false discovery rate (FDR) = 2.11 × 10. -11. ), RIC8A (FDR = 7.05 × 10. -4. ), and SOX12 (FDR = 1.43 × 10. -3. ). Additionally, RIC8A and CHL1 were hypermethylated in responders, while SOX12 was hypomethylated in responders, all showing decreased gene expression. The patterns of cell-specific differential global methylation associated with chondroitin sulphate response were observed. Specifically, we found that DMRs located in TESPA1 and ATP11A exhibited differential DNA methylation between responders and non-responders in granulocytes, monocytes, and B cells. Conclusion. Our study identified cell-specific changes in DNA methylation associated with chondroitin sulphate response in KBD patients. Cite this article:
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:
Aims. This study was performed to investigate the association between the acetabular morphology and the joint space narrowing rate (JSNR) in the non-arthritic hip. Methods. We retrospectively reviewed standing whole-leg radiographs of patients who underwent knee arthroplasty from February 2012 to March 2020 at our institute. Patients with a history of hip surgery, Kellgren-Lawrence grade ≥ II hip osteoarthritis, or rheumatoid arthritis were excluded. The hip JSNR was measured, and the normalized JSNR (nJSNR) was calculated by calibrating the joint space width with the size of the femoral head in 395 patients (790 hips) with a mean age of 73.7 years (SD 8.6). The effects of the lateral centre-edge angle (CEA) and acetabular roof obliquity (ARO) in the standing and supine positions were examined using a multivariate regression model. Results. The mean JSNR and nJSNR were 0.115 mm/year (SD 0.181) and 2.451 mm/year (SD 3.956), respectively. Multivariate regressions showed that older age was associated with a larger nJSNR (p = 0.010, standardized coefficient (SC) 0.096). The quadratic curve approximation showed that the joint space narrowing was smallest when the CEA was approximately 31.9°. This optimal CEA was the same in the standing and supine positions. Multivariate regressions were separately performed for joints with a CEA of < 31.9° and > 31.9°. When the CEA was < 31.9°, a smaller CEA was associated with a larger nJSNR (p < 0.001, SC 0.282). When the CEA was > 31.9°, a larger CEA was associated with a larger nJSNR (p = 0.012, SC 0.152). The ARO was not associated with the nJSNR. Conclusion. Both insufficient coverage and over-coverage of the acetabulum over the femoral head were associated with increased joint space narrowing in hips that were non-arthritic at baseline. The effects of insufficient coverage were stronger than those of overcoverage. Cite this article:
