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Objectives The main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments.Setting Two outpatient clinics.Participants At baseline, 100 patients with radiographic and symptomatic knee osteoarthritis not found eligible for knee replacement (KR) were included. Main exclusion criteria were average score above 75 of the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales pain, symptoms, function of daily living and quality of life; KOOS4 and average knee pain the previous week greater than 60 mm on a 100 mm visual analogue scale.Interventions Patients were randomised to supervised non-surgical treatment consisting of patient education, supervised exercise, weight loss, insoles, and pain medication (the MEDIC treatment) or written advice. The 12-week MEDIC treatment included patient education, neuromuscular exercise, insoles and a dietary weight loss programme and/or pain medication if needed and written advice consisted of two leaflets.Primary and secondary outcome measures Primary outcome was 5-year mean change for KOOS4. Secondary outcomes included KOOS subscales, self-reported health, usage of pain medication and self-reported physical activity.Results Thirty-nine (78%) and 36 (72%) from the MEDIC and written advice groups responded at 5 years. There were no between-group differences in KOOS4 (difference 5.3 (95% CI −1.5 to 12.1) or any secondary outcomes. However, the 95% CI included the minimal clinically important difference for the main outcome.Seventy-six percent of the MEDIC group and 66% of the written advice group experienced clinically important improvements in KOOS4.Fifteen patients (30%) from the MEDIC group and 17 (34%) from the written advice group received KR in the index knee. Undergoing KR did not result in a statistically significant greater improvement in KOOS4 (difference 6.1 (95% CI −1.1 to 13.4).Conclusions No statistically significant differences between supervised non-surgical treatment and written advice were demonstrated at 5 years. Most patients experienced clinically important improvements, irrespective of initial treatment strategy or KR.Trial registration number NCT01535001; ClinicalTrials.gov.

Objectives To investigate the impact of educational level and employment status on change in pain intensity after treatment among patients with knee and hip osteoarthritis (OA).Design A prospective cohort study.Setting and participants We analysed 22 588 patients participating in the Good Life with osteoArthritis in Denmark (GLA:D). GLA:D consists of two patient education sessions and 12 supervised exercise sessions.Primary outcome Baseline educational level and employment status were used as exposures. We investigated the impact of both exposures separately on mean change in pain intensity (visual analogue scale 0–100 mm) from baseline to immediately after treatment (approximately 3 months) and at 12 months, using linear mixed models.Results On average, all patients improved in pain intensity. The average improvement in pain did not differ by educational level, except for one group. Patients with long-term education had less improvement after treatment (2.0 mm, 95% CI 0.8 to 3.1) and at 12 months (2.0 mm, 95% CI 0.6 to 3.4) compared with primary school only (reference). According to employment status, patients on sick leave had the greatest improvement in pain after treatment (−3.4, 95% CI −4.9 to −1.9) and at 12 months (−4.5, 95% CI −6.4 to −2.6) compared with retired patients (reference).Conclusions On average, all patients reported improvement in pain at short-term and long-term follow-up. Change in pain intensity did not substantially differ by educational level or employment status, as the absolute differences were small and most likely not clinically important.

Introduction In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.Methods and analysis This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.Ethics and dissemination The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.Trial registration number EudraCT: No 2015-001200-55; Pre-results.

Objective To assess the 24-month cost-effectiveness of total knee replacement (TKR) plus non-surgical treatment compared with non-surgical treatment with the option of later TKR if needed.Methods 100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care were randomised to TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone. Including quality-adjusted life years (QALYs) data from baseline, 3, 6, 12 and 24 months, effectiveness was measured as change at 24 months. Healthcare costs and transfer payments were derived from national registries. Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs) were calculated. A probabilistic sensitivity analysis was conducted and the probability of cost-effectiveness was estimated at the 22 665 Euros/QALY threshold defined by the National Institute for Health and Care Excellence.Results TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056). While cost-effective in the unadjusted scenario (ICER of 18 497 Euros/QALY), TKR plus non-surgical treatment was not cost-effective compared with non-surgical treatment with the option of later TKR if needed in the adjusted (age, sex and baseline values), base-case scenario (ICER of 32 611 Euros/QALY) with a probability of cost-effectiveness of 23.2%. Including deaths, TKR plus non-surgical treatment was still not cost-effective (ICERs of 46 277 to 64 208 Euros/QALY).Conclusions From a 24-month perspective, TKR plus non-surgical treatment does not appear to be cost-effective compared with non-surgical treatment with the option of later TKR if needed in patients with moderate-to-severe knee osteoarthritis and moderate intensity pain in secondary care in Denmark. Results were sensitive to changes, highlighting the need for further confirmatory research also assessing the long-term cost-effectiveness of TKR.Trial registration number ClinicalTrials.gov (NCT01410409).