Osteoarthritis and cartilage · 2026
Intensive diet or knee arthroplasty for severe knee osteoarthritis: The inka randomised trial.
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Henriksen Marius, Christensen Robin, Poulsen Asbjørn Seenithamby, Bunyoz Kristine Ifigenia, Aljuboori Saber Muthanna, Nielsen Camilla Toft, Haugegaard Tobias, Gudbergsen Henrik, Gromov Kirill, Døssing Anna, Leeds Anthony, Overgaard Søren, Troelsen Anders, Bliddal Henning
Аннотация
OBJECTIVE: To test whether an intensive dietary weight loss program (IN) yields non-inferior symptom improvement vs. knee arthroplasty (KA) in people with knee osteoarthritis eligible for knee arthroplasty.
DESIGN: A non-inferiority, randomised, comparative effectiveness trial involving participants with obesity (body mass index of ≥30 kg/m2) and knee osteoarthritis eligible for knee arthroplasty. After randomisation a 12 week wait list was installed, after which IN participants were offered a 12-week low-calorie meal replacement program with weekly group sessions focusing on behaviour and education supervised by a dietitian and the KA participants were offered surgical insertion of a knee arthroplasty. We aimed to recruit 200 participants. The primary outcome was knee pain and function assessed by the Oxford Knee Score (0-48 score; higher better) 6 months after treatment start, with a prespecified non-inferiority margin of 4 points. Secondary outcomes included change in body weight.
RESULTS: Recruitment target was not reached. 92 participants were randomly assigned to IN (n=45) or KA (n=47). 6 months after treatment start the Oxford Knee Score was 28.2 with IN and 36.5 with KA, with a between-group difference of -8.2 (95%CI, -11.5 to -5.0) favouring KA; the 95% CI did not include the noninferiority margin of 4 points. The mean change in body weight was -11.0 kg (-10.4%) in the IN group and -1.3 kg (-1.2%) in the KA group. The adverse event incidence was similar in the two groups.
CONCLUSION: Among people with obesity and severe knee osteoarthritis eligible for knee arthroplasty a 12-week supervised intensive weight loss program was not non-inferior to knee arthroplasty, shown as clinically inferior improvements in patient reported knee pain and function after 6 months.
TRIAL REGISTRATION: ClinicalTrials.gov number, NCT05172843.
DESIGN: A non-inferiority, randomised, comparative effectiveness trial involving participants with obesity (body mass index of ≥30 kg/m2) and knee osteoarthritis eligible for knee arthroplasty. After randomisation a 12 week wait list was installed, after which IN participants were offered a 12-week low-calorie meal replacement program with weekly group sessions focusing on behaviour and education supervised by a dietitian and the KA participants were offered surgical insertion of a knee arthroplasty. We aimed to recruit 200 participants. The primary outcome was knee pain and function assessed by the Oxford Knee Score (0-48 score; higher better) 6 months after treatment start, with a prespecified non-inferiority margin of 4 points. Secondary outcomes included change in body weight.
RESULTS: Recruitment target was not reached. 92 participants were randomly assigned to IN (n=45) or KA (n=47). 6 months after treatment start the Oxford Knee Score was 28.2 with IN and 36.5 with KA, with a between-group difference of -8.2 (95%CI, -11.5 to -5.0) favouring KA; the 95% CI did not include the noninferiority margin of 4 points. The mean change in body weight was -11.0 kg (-10.4%) in the IN group and -1.3 kg (-1.2%) in the KA group. The adverse event incidence was similar in the two groups.
CONCLUSION: Among people with obesity and severe knee osteoarthritis eligible for knee arthroplasty a 12-week supervised intensive weight loss program was not non-inferior to knee arthroplasty, shown as clinically inferior improvements in patient reported knee pain and function after 6 months.
TRIAL REGISTRATION: ClinicalTrials.gov number, NCT05172843.