Rafael Pinedo-Villanueva

Is surgery for early hip or knee osteoarthritis clinically effective and cost-effective? Osteoarthritis is the most common joint disease worldwide costing between 1% and 2.5% of gross domestic product in developed countries. Once a hip or knee develops end-stage disease, arthroplasty surgery is highly successful in most patients. Treatment options are limited for early disease, and patients may fall into a 'treatment gap', despite having severe symptoms. Many surgical procedures are used to treat early osteoarthritis of the hip and knee, but the clinical and cost-effectiveness of these techniques remains unclear. To investigate the role of surgery in the management of early hip or knee osteoarthritis? Use systematic review and evidence synthesis to determine the clinical effectiveness of current surgical interventions for early hip and knee osteoarthritis. Estimate the cost-effectiveness of these procedures using decision model analytic modelling. Create clinical treatment guidance and identify areas where new clinical research is required. The programme of work consisted of systematic review, evidence synthesis and health economic modelling for surgical treatments used for early hip and knee osteoarthritis. We divided treatments into four groups: (1) non-regenerative procedures, (2) regenerative procedures, (3) load-modifying procedures and (4) arthroplasty procedures. They were compared with non-surgical treatment following National Institute for Health and Care Excellence guidance. We used outcome measures that satisfied the Outcome Measures in Rheumatoid Arthritis Clinical Trials and Osteoarthritis Research Society International core outcome set for hip and knee osteoarthritis. Decision-analytic models were developed to assess the cost-effectiveness of treatment alternatives expressed as cost per quality-adjusted life-year gained. The systematic review identified 61,098 studies, and our evidence synthesis identified a number of surgical techniques that have been used to treat early hip and knee osteoarthritis. However, we found very little meaningful evidence of the clinical efficacy for the majority of the surgical procedures. We only found seven randomised controlled trials and three non-randomised studies that compared a surgical technique to non-operative treatment. There were two surgical treatments that had limited but supportive evidence. Femoro-acetabular impingement is an early stage of hip osteoarthritis, and there is some evidence that arthroscopic chondroplasty provides patients with clinical relief of symptoms, above that seen with non-operative measures. In the knee, weaker evidence suggests arthroscopic debridement of osteoarthritic articular cartilage fragments may be of benefit, above non-operative measures. Health economic analysis suggests that both procedures may be cost-effective, but the evidence is again of low quality. The original updated searches completed in January 2021, with a further search for randomised controlled studies completed in January 2025. There is a significant gap in the evidence base supporting surgical interventions in early hip and knee osteoarthritis. Limited evidence suggests that arthroscopic chondroplasty procedures may be effective in treating hip femoro-acetabular impingement and early knee osteoarthritis. A small number of randomised studies are in progress, but these studies do not encompass all procedures that are in use. The key recommendation for future work is that more high-quality comparative studies are required to establish if the surgical interventions that are currently used are effective. This study is registered as PROSPERO CRD42019156444. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127398) and is published in full in Health Technology Assessment; Vol. 30, No. 56. See the NIHR Funding and Awards website for further award information.

Summary This retrospective study using Swiss health insurance claims data found that 88% of hip and 77% of vertebral fracture patients did not receive osteoporosis treatment within 6 months post-fracture. Purpose The treatment gap in osteoporosis in Switzerland has previously been estimated at 83% based on T-scores and/or FRAX thresholds. However, real-world data on treatment rates following fractures remain limited. This study analysed treatment rates and their predictors in hospitalised patients aged ≥ 50 years with recent vertebral, hip or other fractures and the associated direct economic burden. Methods This retrospective cohort study utilised claims data from the largest Swiss health insurance provider. The incidence of vertebral, hip and other fractures was assessed by age and sex, and treatment rates and predictors of anti-osteoporotic therapies at 12 months post-fracture were analysed. Additionally, hospitalisation duration, associated costs and care trajectories (nursing home placement, rehabilitation, home care services) were described for each fracture site, as well as mortality within 12 and 24 months post-fracture. Results From 2021 to 2023, there were 2458 vertebral, 6229 hip and 11,314 non-hip, non-vertebral fractures (59%, 70% and 74% in women, respectively). Inpatient rehabilitation was required in 8–11% of cases, and 18–21% of patients newly transitioned to nursing home placement within 3 months post-fracture. DXA scans were performed within 12 months in 10% of hip and 21% of vertebral fracture patients and represented the strongest predictor of treatment initiation (odds ratio 10.2, 9.1–11.5), with female sex, older age and greater comorbidity showing weaker effects. Treatment rates within 6 months post-fracture were 11.7% for hip fractures (including 5.0% denosumab, 2.6% zoledronate, 2.1% alendronate), 23% for vertebral fractures (including 9.4% denosumab, 4.7% zoledronate, 3.6% ibandronate, 2.7% anabolic agents) and 12.5% for other fractures, with 8%, 13% and 11% of patients, respectively, already receiving osteoporosis therapy prior to the fracture. Conclusion Osteoporosis treatment rates after hip and vertebral fractures were low, with 88% and 77% of patients, respectively, not receiving treatment within 6 months. DXA scans, specialist consultations and comorbidity burden were the strongest predictors of post-fracture treatment, highlighting key patient- and system-level factors that could guide interventions to close the treatment gap.

Background: Digital nerves provide sensibility to the fingers. They are commonly injured through accidental sharp laceration. The aim of the NEON (Nerve rEpair Or Not) study was to investigate whether microsurgical suture repair of lacerated digital nerves is superior to nerve alignment alone without suture repair. Methods: A two-arm, parallel group, double-blind, multicentre RCT was undertaken over 2 years. Participants with suspected unilateral digital nerve injury underwent surgical exploration and were randomized to microsurgical suture repair or nerve alignment alone. The primary outcome was the Impact of Hand Nerve Disorders (I-HaND v2) patient-reported outcome measure (PROM) at 12 months post-randomization. Secondary outcomes assessed were: objective neurosensory and functional recovery; health-related quality of life to examine cost-effectiveness; complications of surgery and clinically problematic neuroma rates (Elliot score). Both participants and assessors were blind to allocation. Results: A total of 122 adults were randomized to microsurgical suture repair (n = 61) or nerve alignment alone (n = 61). Primary outcome data using the I-HaND (v2) were available for 106 participants (87%) at 12 months. There were no statistically significant differences in I-HaND scores at all time points, including the 12-month primary end point (15.9 versus 20.2, P = 0.09; 95% c.i. [−0.9, 10.8]). There were also no differences in all secondary outcome measures, including Patient Evaluation Measure and EQ-5D-5L scores at 12 months. Complications were similar at 6 weeks and 12 months. The trial was closed early by the funder owing to slow recruitment and did not reach the intended sample size. Conclusion: Based on the available data from the NEON trial, there is no evidence to support the beneficial effect of suture repair over nerve alignment alone for isolated digital nerve injury. This multicentre RCT can be used to inform future trials, inform patients and guide clinical practice. Funding: NIHR Health Technology Assessment (NIHR127807–18/37). Trial registration number: ISRCTN16211574

Background and purpose: Patients receiving total hip arthroplasty (THA) have different expectations and concerns about their health outcomes after surgery. In this study we developed a tool based on registry data to inform patients and their clinicians about activity outcomes after THA. Methods: We used data from the Geneva Arthroplasty Registry (GAR) on patients receiving a primary elective THA between 1996 and 2019. The information tool was developed around five activity outcomes: getting in/out of the car, getting dressed autonomously, independence in weekly tasks, interference in social activities, and activity levels. Based on baseline predictors, conditional inference trees (CITs) were used to create clusters of patients with homogeneous activity outcomes at one, five and 10 years after surgery, rather than to predict individual probabilities. Results: In total, 14 CITs were generated based on 6,836 operations included in the tool. Overall, activity outcomes substantially improved at all three times points after surgery, with 1-year values mostly being the highest. While before surgery only about 10% of patients had none/slight limitations in activities of daily living, about 70% did one year after surgery. The SF12 mental component score (MCS), SF12 self-rated health (SRH), BMI, ASA score, and comorbidity count were the most recurring predictors of activity outcomes. Predictors and their relative importance changed at different time points for the same outcome. For example, for ability to get in/out the car, whilst clusters at year 1 were generated based on WOMAC function, SRH, mental health, WOMAC difficulty walking, and SF12 physical interference, at year 5, ASA score, BMI, SF12 physical & mental health, activity level, and socio-economic status were significant. Outcome profiles varied by clusters. Conclusion: Distinct activity outcomes clusters based on baseline patient characteristics were identified and knowing this can help inform patients’ expectation and meaningful discussions with clinicians about treatment decisions.

X-linked hypophosphatemia (XLH) is a rare genetic disorder that leads to rickets, osteomalacia, and other skeletal abnormalities. Many people with XLH get support from informal caregivers, often family members, to help with their daily living. Although generally rewarding, being a caregiver can be associated with extra physiologic, physical, and mental health burdens, which are poorly researched and understood. This study aims to investigate the quality of life of people with XLH who are also caregivers of relatives with XLH. To do this, we conducted a cross-sectional study to characterize the quality of life of caregivers using both a caregiver-specific and a generic quality of life questionnaire, examined the association between the instruments for caregivers, and compared the generic quality of life between caregivers and matched non-caregivers. We used data from the Rare UK Diseases Study (RUDY), whose platform allows people with XLH to record their own characteristics and outcome measures, including the caregiver oncology quality of life questionnaire (CarGOQoL) and the generic EQ-5D. Caregivers and non-caregivers with XLH were matched on gender and age. Caregivers (n = 13) report not feeling burdened or seeing their self-esteem impacted by providing care, but their private life, leisure, and psychological well-being were affected. They report worse quality of life than the UK general population. CarGOQoL and EQ-5D were highly correlated (p < .001). Caregivers of people with XLH reported better quality of life than non-caregivers in all EQ-5D dimensions except for Anxiety/Depression (EQ-5D score of 0.467 vs 0.356 for non-caregivers). Our findings must be interpreted with caution, given the small sample size, although they are consistent with the literature. Caregivers play an important role in supporting the everyday life of those they look after. This role should be recognized, and helpful information and tools made available to support them in that process.

Aims: Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050. This protocol describes a platform trial framework, designed to efficiently deliver multiple randomized comparisons of interventions for patients with a fragility hip fracture.Methods: All patients aged 60 years and over with a hip fracture presenting to the World Hip Trauma Evaluation (WHiTE) recruitment centres will be considered for eligibility for each of the randomized comparisons appended to the platform at the time of recruitment. They will be offered the opportunity to take part in any or all of the randomized comparisons for which they are eligible. Comparisons may be contemporaneous or distributed throughout the treatment pathway. This master protocol describes the trial procedures, core dataset, and documentation. It describes those components of the research process which will be consistent between randomized comparisons. Where additional procedures are planned, specific to a randomized comparison, these will be described in a separate appendix protocol for that randomized comparison.Conclusion: The WHiTE platform trial will provide randomized evidence regarding the clinical and cost-effectiveness of interventions to improve outcomes for patients with fragility hip fracture. Findings will inform national and international policy and practice guidelines for the management of patients with a hip fracture.Cite this article: Bone Jt Open 2025;6(4):383–390.

Artificial intelligence (AI) algorithms have been developed to identify vertebral fractures through reanalysis of existing CT scans. This study describes a real-world case study of the deployment of an AI solution in the NHS, from information governance (IG) and technology (IT) perspectives, to inform best practice recommendations. Five NHS hospitals were selected to deploy the Nanox AI solution to identify vertebral fractures from existing CT images. The journey to IG and IT assurance was described and used to inform recommendations. The time from contract signing to IG assurance ranged between 5 and 13 months. The period from IG assurance to the analysis of the first patient scan ranged from 7 to 12 months, excluding 1 site withdrawing from the process. Each site required different IG documents: Data Protection Impact Assessment (5/5 sites), Data Protection Agreement (2/5 sites), Digital Technology Assessment Criteria (2/5 sites). IT implementation delays included third-party supplier coordination, NHS IT staff availability, and local capability. Based on the observed challenges, 6 best practice recommendations are proposed to address current challenges to AI adoption in radiology settings in the NHS to support IG and 8 to support IT implementation services. Significant challenges remain if AI is to be routinely used to identify vertebral fractures. The proposed recommendations provide a pathway to improve effective and efficient AI deployment. This study proposes recommendations from IG and IT perspectives to improve the local deployment of AI in the NHS.

Background: The aim of this project was to develop a tool using the experience of previous patients to inform patient-centred clinical decision-making in the context of total hip arthroplasty (THA). We sought out the patients’ views on what is important for them, leveraging registry data, and providing outcome information that is perceived as relevant, understandable, adapted to a specific patient’s profile, and readily available. Methods: We created the information tool “Patients like me” in four steps. (1) The knowledge basis was the systematically collected detailed exposure and outcome information from the Geneva Arthroplasty Registry established 1996. (2) From the registry we randomly selected 275 patients about to undergo or having already undergone THA and asked them via interviews and a survey which benefits and harms associated with the operation and daily life with the prosthesis they perceived as most important. (3) The identified relevant data (39 predictor candidates, 15 outcomes) were evaluated using Conditional Inference Trees analysis to construct a classification algorithm for each of the 15 outcomes at three different time points/periods. Internal validity of the results was tested using bootstrapping. (4) The tool was designed by and pre-tested with patients over several iterations. Results: Data from 6836 primary elective THAs operated between 1996 and 2019 were included. The trajectories for the 15 outcomes from the domains pain relief, activity improvement, complication (infection, dislocation, peri-prosthetic fracture) and what to expect in the future (revision surgery, need for contralateral hip replacement) over up to 20 years after surgery were presented for all patients and for specific patient profiles. The tool was adapted to various purposes including individual use, group sessions, patient-clinician interaction and surgeon information to complement the preoperative planning. The pre-test patients’ feedback to the tool was unanimously positive. They considered it interesting, clear, complete, and complementary to other information received. Conclusion: The tool based on a survey of patients’ perceived concerns and interests and the corresponding long-term data from a large institutional registry makes past patients’ experience accessible, understandable, and visible for today’s patients and their clinicians. It is a comprehensive illustration of trajectories of relevant outcomes from previous “Patients like me”. This principle and methodology can be applied in other medical fields.

Objectives To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. Design Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. Setting Public hospitals and publicly funded procedures at private hospitals in England, 2012-20. Participants Adults aged 60 years or older who underwent RTSR or TSR for osteoarthritis with intact rotator cuff tendons. Patients were identified from the National Joint Registry and linked to NHS Hospital Episode Statistics and civil registration mortality data. Propensity score matching and inverse probability of treatment weighting were used to balance the study groups. Main outcome measures The main outcome measure was revision surgery. Secondary outcome measures included serious adverse events within 90 days, reoperations within 12 months, prolonged hospital stay (more than three nights), change in Oxford Shoulder Score (preoperative to six month postoperative), and lifetime costs to the healthcare service. Results The propensity score matched population comprised 7124 RTSR or TSR procedures (126 were revised), and the inverse probability of treatment weighted population comprised 12 968 procedures (294 were revised) with a maximum follow-up of 8.75 years. RTSR had a reduced hazard ratio of revision in the first three years (hazard ratio local minimum 0.33, 95% confidence interval 0.18 to 0.59) with no clinically important difference in revision-free restricted mean survival time, and a reduced relative risk of reoperations at 12 months (odds ratio 0.45, 95% confidence interval 0.25 to 0.83) with an absolute risk difference of −0.51% (95% confidence interval −0.89 to −0.13). Serious adverse events and prolonged hospital stay risks, change in Oxford Shoulder Score, and modelled mean lifetime costs were similar. Outcomes remained consistent after weighting. Conclusions This study’s findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact rotator cuff tendons. Despite a significant difference in the risk profiles of revision surgery over time, no statistically significant and clinically important differences between RTSR and TSR were found in terms of long term revision surgery, serious adverse events, reoperations, prolonged hospital stay, or lifetime healthcare costs.