Beth Lineham

Background: Patients with symptoms of pain and restricted function related to knee osteoarthritis are typically offered a knee replacement. However, a proportion remain dissatisfied with their outcomes, and the failure risk is disproportionately higher in the young. Knee joint distraction may be an intervention to postpone the time to knee replacement in this patient population. Objective and main outcome measure: The primary objective of the Knee Arthroplasty versus Joint Distraction Study for Osteoarthritis (KARDS) was to evaluate the effectiveness of knee joint distraction compared to knee replacement based on patient-reported pain 12 months post surgery using the Knee Injury and Osteoarthritis Outcomes Score pain score as the primary outcome. Design and methods: KARDS was an open-label, two-arm individually randomised controlled non-inferiority trial with an embedded 12-month internal pilot phase and process evaluation to evaluate recruitment feasibility. A hybrid expertise design was used to account for surgeon expertise and potential lack of individual equipoise. The trial was closed to recruitment early following cessation of elective orthopaedic surgery secondary to COVID-19 pandemic. Descriptive statistics are reported. Setting: United Kingdom National Health Service Trusts. Participants: Adult patients aged < 65 years with symptoms severe enough to warrant knee replacement, in the opinion of the treating clinician. Interventions: Participants were randomised to receive either knee joint distraction (static distraction of 5 mm, using external fixator for 6 weeks) or knee replacement. Results: Twenty-four participants were randomised from a single centre between March 2021 and October 2022 with minimum 3-month safety follow-up post surgery. Eleven participants were randomised to knee joint distraction and 13 to knee replacement. Seventeen patients were male (71%), median age 60 (47–65) years. One patient withdrew due to being medically unfit for surgery and two received a different treatment than which they were randomised (one crossover from each arm). The median Knee Injury and Osteoarthritis Outcomes Score pain score in the knee joint distraction group improved from 38.9 (22–50) at baseline to 55.6 (0–100) at 12 months, corresponding scores in the knee replacement improved from 30.6 (6–36) to 75.0 (50–100). Adverse events were more common with knee joint distraction, pin site infection being the commonest complications ( n = 4, 58%). As part of process evaluation, we conducted semistructured qualitative interviews with staff in secondary care and with study participants. Data were analysed using thematic content analysis. One overarching theme emerged: ‘An unexpected journey’, which encapsulates staff and participants’ experiences. Conclusion: Reduced research capacity and the suspension of elective surgery following the COVID-19 pandemic caused significant recruitment barriers. Despite early termination, KARDS demonstrated that patients were willing to be recruited to a trial investigating a novel treatment for knee osteoarthritis and the trial was feasible and implementable. The limited results indicated that the technique is safe with no safety concerns. Clinical and cost-effectiveness of knee joint distraction remains uncertain. The embedded KARDS process evaluation has provided helpful insights. Limitations: Reduced research capacity at sites and suspension of elective surgery services within the United Kingdom following COVID-19 caused significant recruitment barriers to KARDS. All the recruited patients in both arms of the study were White. Future work: As a commissioned piece of research with delivery significantly impacted by the National Health Service environment post-COVID and the impact on National Health Service surgical services, the research question remains highly relevant. Any future research in this field can be helped by the pilot data published here along with the lessons learnt. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/122/06.

Aims: Knee joint distraction (KJD) has been proposed as a joint-preserving alternative to arthroplasty. The objective of this study was to evaluate the clinical and cost-effectiveness of KJD compared to arthroplasty for knee osteoarthritis.Methods: This phase III multicentre, pragmatic, randomized controlled non-inferiority trial recruited adults aged ≤ 65 years with symptomatic osteoarthritis refractory to non-surgical treatment and suitable for knee arthroplasty. Patients were randomized to static, linear, KJD of 5 mm, produced with an external fixator construct for six-week duration, or total knee arthroplasty. The primary outcome measure was the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain subscale 12 months post-surgery. The trial was terminated early due to failure to recruit following cessation of elective orthopaedic surgery during the COVID-19 pandemic.Results: A total of 24 participants were randomized with baseline characteristics balanced between groups. Improved median KOOS pain scores at 12 months postoperatively were observed in both treatment groups. The median KOOS pain score in the KJD group improved from 38.9 (IQR 30.6 to 41.7) at baseline to 55.6 (IQR 41.7 to 94.4) at 12 months, while corresponding scores in the arthroplasty group improved from 30.6 (IQR 11.1 to 36.1) to 75.0 (IQR 66.7 to 88.9). Similar improvements following KJD were seen across other KOOS subdomains and pain VAS, range of motion, or timed up-and-go test. The small sample size does not provide sufficient information to make meaningful comparisons between treatment groups. Pin site infection was seen in two patients, and a fracture through a pin site after frame removal following trauma in one patient.Conclusion: KJD appears to be associated with improved pain and function compared to baseline. The clinical and cost-effectiveness of KJD compared to arthroplasty remains uncertain.Cite this article: Bone Jt Open 2025;6(8):886–893.

Purpose: To explore the historical case of Saint Ignatius of Loyola’s leg injury and subsequent surgical interventions as a potential early instance of limb lengthening and reconstruction surgery. Methods: A detailed analysis of “A Pilgrim’s Journey” (Ignatius of Loyola’s autobiography) was conducted, focusing on orthopaedic descriptions of his injury and treatments. Results: In 1521, Íñigo López de Loyola sustained a severe, comminuted open fracture of the tibia due to a cannonball wound during the siege of Pamplona. Initial attempts at reduction were unsuccessful, leading to a non-union with significant deformity and shortening. He underwent a revision surgery, a procedure described as “carnage” and endured without a single lament. Although the fracture eventually united, residual shortening and a prominent bone deformity persisted. Unwilling to accept this disfigurement for social reasons, Ignatius requested a second, highly painful osteotomy to remove the protruding bone followed by continuous traction for “days and days of martyrdom” for progressive lengthening. Crucially, after these arduous treatments, Ignatius was able to walk and even ride a horse again. The only significant residual symptom was swelling in his leg by evening. Conclusion: St. Ignatius of Loyola’s case provides a compelling historical account of complex orthopaedic challenges in the early 16th century. The documented surgeries represent remarkably early attempts at managing non-union, deformity, and potentially achieving limb lengthening, predating modern reconstructive techniques by centuries. This historical narrative offers valuable insights into the nascent stages of orthopaedic surgery and highlights how a physical ordeal can profoundly shape one’s life path.

Knee joint distraction (KJD) is a potential technique for cartilage regeneration in young patients with osteoarthritis of the knee. Static distraction has been utilised typically; however, a significant proportion of patients complain of knee stiffness post-distractor removal. The use of a hinged distractor may reduce the duration and severity of post-treatment knee stiffness by maintaining the range of motion during distraction. Furthermore, improved cartilage regeneration has been demonstrated in hinged ankle joint distraction as compared to static, and this may also be demonstrated at the knee. An evidence review was undertaken to inform further research and a potential change in practice. A systematic review of all primary research on hinged knee joint distraction for cartilage regeneration. An online systematic search of citation databases was conducted. Quality assessment and data extraction were undertaken by two separate researchers. The literature search returned a small number of relevant studies, of which 7 were included. Three of these were animal studies, two cadaveric and two case series. The study quality was low or very low. There was significant methodological heterogeneity with difficulties encountered in the transfer of constructs from animal and cadaveric studies to humans. Issues faced included difficulties with hinge placement and pin site pain in motion. The feasibility of hinged knee joint distraction has yet to be proven. Any further research attempting to establish the benefits of hinged-over static knee distraction will have to take construct design considerations into account. Lineham B, van Duren B, Harwood P, et al. The Feasibility of Hinged Knee Arthrodiastasis for Cartilage Regeneration: A Systematic Review of the Literature. Strategies Trauma Limb Reconstr 2023;18(1):37–43.

No entirely reliable method to assess union during Ilizarov treatment exists. Premature frame removal results in treatment failure, and alternative methods of assessment warrant investigation. Wire deflection might provide an indication of fracture site deformation on weight-bearing, indicating progress towards union. A previous in vitro study from our group demonstrated this approach may be clinically applicable. We investigated translation of this method into clinical practice in an observational pilot study. Patients with tibial shaft fractures treated with Ilizarov frames were recruited. A prototype depth gauge was used to measure wire deflection on weight-bearing. Investigators undertaking the measurement were blinded to the clinical stage of treatment, and clinicians caring for the patient were blinded to deflection results. Patient records were reviewed at the end of treatment to determine likely fracture stability at each time point. Deflection per kg of weight applied, per mm from the ring was compared between stable and unstable situations. Thirty-one measurements were obtained in 14 patients. The situation was deemed stable at 13 and unstable at 18 measurements. The median deflection in the stable group was 0.030 microns/kg/mm (IQR 0.005–0.104) and 0.165 microns/kg/mm (IQR 0.072–0.328) in the unstable group. This difference was statistically significant (Wilcoxon Mann–Whitney test p = 0.0014). ROC curve analysis revealed that wire deflection was able to predict clinical stability (AUC 0.84, p <0.0001). Various technical problems were encountered when using the device which would potentially limit its clinical utility in its current form. In this set of observations, wire deflection was significantly associated with clinically and radiologically determined stability. Though various practical limitations were encountered in using the prototype measurement device, this proof-of-concept study supports further development of this approach. The research group plan to develop a smaller, more reliable device for further clinical testing in a larger group of patients. Lineham B, Stewart T, Ward J, et al. Measurement of Wire Deflection on Loading may Indicate Union in Ilizarov Constructs: A Pilot Study. Strategies Trauma Limb Reconstr 2021;16(3):132–137.

No entirely reliable method exists for assessing union during Ilizarov treatment. Premature removal results in potential treatment failure; hence, alternative methods warrant investigation. Wire deflection might provide an indication of fracture site deformation on weight bearing, indicating progress towards union. This study aimed to test a method for assessing wire deflection within an Ilizarov frame. (1) To assess the repeatability of our novel measurement method in measuring wire deflection within an Ilizarov frame in vitro. (2) To compare the amount of wire deflection in an unstable model with that in an intact bone model. (3) To assess accuracy of this method by comparing wire deflection measured with overall machine extension. Tests were performed on clinical grade-tensioned fine wire 4-ring Ilizarov constructs stabilising a simulated fracture, with and without an unstable defect. Models were sequentially loaded to 700 N using an Instron testing machine. A digital depth gauge attached to the superior ring measured relative wire displacement at the ring closest to the fracture. Tests were repeated 3 times. (1) Both unstable and stable bone models produced highly repeatable load deformation curves (R² = 0.98 and 0.99). (2) In the unstable model, wires tensioned at 882 and 1274 N produced mean maximum deflections of 2.41 and 2.69 mm compared with 0.05 and 0.04 mm in the intact bone model (significant p < 0.0001). (3) Wire deflection and machine extension results were strongly correlated (r = 0.99). A measurable difference in wire deflection between stable and unstable situations exists using this method which appears accurate and repeatable, with clear correlation between displacement and load and displacement and machine extension. This approach might be clinically applicable, and further clinical testing is required.