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Knee arthroplasty compared with joint distraction for osteoarthritis: a phase III randomized controlled trial
Thomas W Hamilton1, Beth Lineham2,3, Deborah D Stocken4
1Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Bone & Joint Open
|August 5, 2025
Summary
Knee joint distraction (KJD) shows potential for improving pain and function in osteoarthritis patients. However, its clinical and cost-effectiveness compared to knee arthroplasty remains uncertain due to limited data.
Area of Science:
- Orthopedics
- Regenerative Medicine
- Biomechanical Engineering
Background:
- Knee osteoarthritis (OA) is a leading cause of disability.
- Total knee arthroplasty (TKA) is a common treatment, but carries risks and costs.
- Knee joint distraction (KJD) offers a joint-preserving alternative to TKA.
Purpose of the Study:
- To evaluate the clinical and cost-effectiveness of KJD versus TKA for knee OA.
- To compare outcomes using the Knee injury and Osteoarthritis Outcomes Score (KOOS) and other functional measures.
Main Methods:
- Phase III multicentre, randomized controlled non-inferiority trial.
- Recruited adults aged ≤ 65 with symptomatic knee OA refractory to conservative treatment.
- Patients randomized to 6-week KJD or TKA; primary outcome: KOOS pain subscale at 12 months.
- Trial terminated early due to recruitment failure during COVID-19 pandemic.
Main Results:
- 24 participants randomized; baseline characteristics balanced.
- Both KJD and TKA groups showed improved KOOS pain scores at 12 months.
- KJD showed improvement from 38.9 to 55.6; TKA improved from 30.6 to 75.0.
- Small sample size precludes meaningful between-group comparisons.
- Adverse events included pin site infections and a fracture.
Conclusions:
- Knee joint distraction (KJD) appears to improve pain and function from baseline.
- The clinical and cost-effectiveness of KJD compared to knee arthroplasty remains uncertain.
- Further research with larger sample sizes is needed to confirm efficacy.
