Ruth Knight

Aims: The aim of this study was to assess the feasibility of conducting a randomized controlled trial (RCT) to test the effectiveness of an online, biopsychosocial intervention for the management of recovery in patients with complex lower-limb orthopaedic trauma. Methods: This was a multicentre, parallel-group, randomized feasibility trial with an embedded qualitative study. Patients were recruited from four UK NHS major trauma centres if they were aged ≥ 16 years and had undergone surgery for complex lower-limb orthopaedic trauma. They were randomized to gain access to a biopsychosocial support website to target psychological predictive factors of poor outcomes for three months in addition to routine care, plus four one-to-one sessions with healthcare professionals to increase adherence, compared with routine care only. The primary outcome was patient acceptance, and secondary outcomes were the patients’ adherence and intervention delivery fidelity. Results: A total of 57 of 112 eligible patients (51%) participated (≥ 50% study feasibility criterion) and a mean of 2.7 were recruited per centre per month (≥ 2 criterion). They attended a median of three out of four sessions (3 to 4 criterion). However, the intervention delivery fidelity criterion (≥ 90% of intervention providers deliver the intervention as per manual) was not met (58% observed). The retention criterion (< 20% loss to follow-up at three months) was also not met (49% observed). Conclusion: The intervention was feasible in terms of patient acceptance; however, it needs to be modified to increase patient adherence and delivery fidelity. Cite this article: Bone Joint J 2026;108-B(6):818–826.

Summary This study assessed the effect of adding an adherence support intervention to exercises for vertebral fragility fractures. The findings showed the intervention group demonstrated significantly better outcomes for Timed-up and Go test and 6 min walk test. Additional support for exercise behaviour provided greater benefits than exercise alone. Purpose To investigate whether an exercise rehabilitation programme with integrated adherence support would be more effective than exercise alone. Methods Two-arm, individually randomised controlled trial with concealed allocation, assessor blinding and intention to treat analysis. Participants. One hundred twenty-six people over 55 years with at least one vertebral fragility fracture and back pain; 63 per group. Both arms received progressive exercise rehabilitation including strength, posture and balance exercises. Additionally, the intervention arm received an integrated exercise adherence intervention that utilised a motivational interviewing approach, goal setting and ≥ 3 behaviour change techniques to support exercise behaviour. The primary outcome was the Timed-Up and Go (TUG) at 12 months. Secondary outcomes included quality of life (QUALEFFO-41), thoracic kyphosis, standing balance (functional reach: FR), muscle strength (timed loaded standing: TLS) and walking exercise capacity (6-min walk: 6MW). Results At 12 months, 57 intervention and 55 control participants were analysed. Clinically relevant, statistically significant gains were seen favouring the intervention group in TUG mean 10.1 (SE 0.38) seconds versus mean 12.9 s; effect size, 2.1 s; 95% CI, − 3.1 to − 1.0 s; p = 0.000) and 6MW mean 354.6 (SE 6.6) m versus control 325.7 (SE 6.9) m, effect size 24.5 m, 95% CI, 5.7 to 43.4 m, p = 0.011). There were no significant differences in the other outcome measures and no related adverse events. Conclusions This RCT found integrated, additional support for exercise behaviour within a programme of physiotherapy rehabilitation for people with VFF provided greater benefits to lower extremity function, balance and walking at 12 months as measured by the TUG and 6MW tests.

Aims: The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.Methods: The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.Results: A total of 1,015 of the original patients (66%) provided at least one set of outcome data during the five years of follow-up. There was no evidence of a difference in patient-reported disability between the two groups at five years (NPWT group mean DRI 30.0 (SD 26.5), standard dressing group mean DRI 31.5 (SD 28.8), adjusted difference -0.86 (95% CI -4.14 to 2.40; p = 0.609). There was also no evidence of a difference in the complication rates at this time.Conclusion: We found no evidence of a difference in disability ratings between NPWT compared with standard wound dressings in the five years following the surgical treatment of a complex fracture of the lower limb. Patients in both groups reported high levels of persistent disability and reduced quality of life, with little evidence of improvement during this time.Cite this article: Bone Joint J 2024;106-B(8):858–864.

Objectives To investigate trends in the incidence rate and main indication for revision hip replacement (rHR) over the past 15 years in the UK. Design Repeated national cross-sectional study from 2006 to 2020. Setting/participants rHR procedures were identified from the National Joint Registry for England, Wales, Northern Ireland, the Isle of Man and the States of Guernsey. Population statistics were obtained from the Office for National Statistics. Main outcome measures Crude incidence rates of rHR. Results The incidence rate of rHR doubled from 11 per 100 000 adults in 2006 (95% CI 10.7 to 11.3) to a peak of 22 per 100 000 adults (95% CI 22 to 23) in 2012, before falling to 17 per 100 000 adults in 2019 (95% CI 16 to 17) (24.5% decrease from peak). The incidence rate of rHR reduced by 39% in 2020 compared with 2019 (during the COVID-19 pandemic). The most frequent indications for rHR between 2006 and 2019 were loosening/lysis (27.8%), unexplained pain (15.1%) and dislocation/instability (14.7%). There were incremental increases in the annual number and incidence rates of rHR for fracture, infection, dislocation/instability and a decrease in rHR for aseptic loosening/lysis. Conclusions The incidence rate of rHR doubled from 2006 to 2012, likely due to high early failure rates of metal-on-metal hip replacements. The incidence of rHR then decreased by approximately 25% from 2012 to 2019, followed by a large decrease during the COVID-19 pandemic. The decrease in the number of rHR performed for aseptic loosening/lysis may reflect improved wear and implant longevity. Increased healthcare resource will be required to care for the increasing numbers of patients undergoing rHR for fracture and infection.

Background: The purpose of this study was to investigate patient-relevant outcomes following first revision total knee arthroplasties (rTKAs) performed for different indications. Methods: This population-based cohort study utilized data from the United Kingdom National Joint Registry, Hospital Episode Statistics Admitted Patient Care, National Health Service Patient-Reported Outcome Measures, and the Civil Registrations of Death. Patients undergoing a first rTKA between January 1, 2009, and June 30, 2019, were included in our data set. Patient-relevant outcomes included implant survivorship (up to 11 years postoperatively), mortality and serious medical complications (up to 90 days postoperatively), and patient-reported outcome measures (at 6 months postoperatively). Results: A total of 24,540 first rTKAs were analyzed. The patient population was 54% female and 62% White, with a mean age at the first rTKA of 69 years. At 2 years postoperatively, the cumulative incidence of re-revision surgery ranged from 2.7% (95% confidence interval [CI], 1.9% to 3.4%) following rTKA for progressive arthritis to 16.3% (95% CI, 15.2% to 17.4%) following rTKA for infection. The mortality rate at 90 days was highest following rTKA for fracture (3.6% [95% CI, 2.5% to 5.1%]) and for infection (1.8% [95% CI, 1.5% to 2.2%]) but was <0.5% for other indications. The rate of serious medical complications requiring hospital admission within 90 days was highest for patients treated for fracture (21.8% [95% CI, 17.9% to 26.3%]) or infection (12.5% [95% CI, 11.2% to 13.9%]) and was lowest for those treated for progressive arthritis (4.3% [95% CI, 3.3% to 5.5%]). Patients who underwent rTKA for stiffness or unexplained pain had some of the poorest postoperative joint function (mean Oxford Knee Score, 24 and 25 points, respectively) and had the lowest proportion of responders (48% and 55%, respectively). Conclusions: This study found large differences in patient-relevant outcomes among different indications for first rTKA. The rate of complications was highest following rTKA for fracture or infection. Although rTKA resulted in large improvements in joint function for most patients, those who underwent surgery for stiffness and unexplained pain had worse outcomes. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Introduction: Neuropathic pain is prevalent among people after lower limb fracture surgery and is associated with lower health-related quality of life and greater disability. This study estimates the financial cost and pain medication use associated with neuropathic pain in this group. Methods: A secondary analysis using pain data collected over six postoperative months from participants randomised in the Wound Healing in Surgery for Trauma (WHiST) trial. Pain states were classified as pain-free, chronic non-neuropathic pain (NNP) or chronic neuropathic pain (NP). Cost associated with each pain state from a UK National Health Service (NHS) and personal social services (PSS) perspective were estimated by multivariate models based on multiple imputed data. Pain medication usage was analysed by pain state. Results: A total of 934 participants who provided either 3- or 6-months pain data were included. Compared to participants with NP, those with NNP (adjusted mean difference -£730, p = 0.38, 95% CI −2368 to 908) or were pain-free (adjusted mean difference -£716, p = 0.53, 95% CI −2929 to 1497) had lower costs from the NHS and PSS perspective in the first three postoperative months. Over the first three postoperative months, almost a third of participants with NP were prescribed opioids and 8% were prescribed NP medications. Similar trends were observed by 6 months postoperatively. Conclusion: This study found healthcare costs were higher amongst those with chronic NP compared to those who were pain-free or had chronic NNP. Opioids, rather than neuropathic pain medications, were commonly prescribed for NP over the first six postoperative months, contrary to clinical guidelines.

Background: People with avascular necrosis of the hip have very limited treatment options currently available to stop the progression of this disease; this often results in the need for a hip replacement. There is some weak evidence that a class of drugs called bisphosphonates may delay the course of the disease, and this trial was commissioned and set up to provide robust evidence regarding the use of bisphosphonates in adults aged ≥ 18 years with this condition. Objectives: The aim of the Managing Avascular Necrosis Treatments: an Interventional Study (MANTIS) trial was to evaluate the clinical effectiveness and cost-effectiveness of a 12-month course of alendronate in the treatment of avascular necrosis. Design: This was a 66-month, definitive, multisite, two-arm, parallel-group, placebo-controlled, double-blind, randomised controlled trial, with an internal pilot phase. Setting: Eight secondary care NHS hospitals across the UK. Participants: Planned trial size – 280 adult patients with avascular necrosis. Intervention: Participants in the intervention group received 70 mg of alendronate (an oral bisphosphonate) weekly for 12 months. Main outcomes: The main outcomes were Oxford Hip Score at 12 months (short-term outcome) and the time to decision that a hip replacement is required at 36 months (long-term outcome). Results: Twenty-one patients were recruited and randomised to receive either the intervention drug, alendronate, or a placebo-matched tablet. Limitations: This trial was principally limited by low disease prevalence. Other limitations included the late disease stage at which participants were identified and the rapid progression of the disease. Future work: This trial was limited by a low recruitment rate. Avascular necrosis of the hip should be treated as a rare disease. Future trials would need to recruit many more sites and recruit over a longer time period, and, for this reason, a registry may provide a more effective means of collecting data pertaining to this disease. Conclusions: The MANTIS trial was terminated at the end of the pilot phase, because it did not meet its go/no-go criteria. The main issue was a poor recruitment rate, owing to a lower than expected disease prevalence and difficulties in identifying the condition at a sufficiently early stage. Those patients who were identified and screened either were too advanced in their disease progression or were already taking medication. We would not recommend that a short-term interventional study is conducted on this condition until its prevalence, geographic foci and natural history and better understood. The difficulty of acquiring this understanding is likely to be a barrier in most health-care markets. One means of developing this understanding would be the introduction of a database/registry for patients suffering from avascular necrosis of the hip. Trial registration: The trial is registered as ISRCTN14015902. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 43. See the NIHR Journals Library website for further project information.

Aims: The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence. Methods: Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function. Results: Previously described measures of RM and surgeon opinion of clinically significant malunion (CSM) were shown to be related but with important differences. CSM was more strongly related to outcome (-13.9 points on the OMAS; 95% confidence interval (CI) -21.9 to -5.4) than RM (-5.5 points; 95% CI -9.8 to -1.2). Existing malunion thresholds for talar tilt and tibiofibular clear space were shown to be slightly conservative; new thresholds which better explain function were identified (talar tilt > 2.4°; tibiofibular clear space > 6 mm). Based on this new definition the presence of RM had an impact on function, which was statistically significant, but the clinical significance was uncertain (-9.1 points; 95% CI -13.8 to -4.4). In subsequent analysis, RM of a posterior malleolar fracture was shown to have a statistically significant impact on OMAS change scores, but the clinical significance was uncertain (-11.6 points; 95% CI -21.9 to -0.6). Conclusion: These results provide clinical evidence which supports the previously accepted definitions. Further research to investigate more conservative clinical thresholds for malunion is indicated. Cite this article: Bone Jt Open 2022;3(10):841–849.