F. Lafeber (Utrecht, NL)
University Medical Centre Utrecht Rheumatology and Clinical ImmunologyPresenter Of 1 Presentation
18.3.7 - Grip on Knee Osteoarthritis: Joint Distraction Versus Arthroplasty (GODIVA) - A Large Randomized Controlled Multicenter Trial
Abstract
Purpose
For relatively young (≤65 year) patients with end-stage knee osteoarthritis (OA) with persistent, pain, insufficiently responding to conservative management, knee arthroplasty (KA) is a frequently applied treatment. A primary KA in this age group often requires revision surgery later in life. Revision surgery is complex, costly, and accompanied by multiple complications. Knee joint distraction (KJD) is a joint preserving treatment that delays the need for primary KA. KJD has proven to be effective in reducing pain and stiffness and improving function in studies (Jansen M, et al. Cartilage 2020). In a pilot study KJD was slightly less effective than KA, although not statistically significant (Jansen M, et al. Cartilage 2021). Therefore, this study aims to determine whether KJD is non-inferior on patient reported outcome as compared to KA for these patients.
Methods and Materials
Pragmatic, open, randomized, multi-centre (fig), non-inferiority trial with 2 year follow-up. 1,200 knee OA patients ≤65 year indicated for a KA are randomized (1:1) to KJD or KA. KA and KJD are indicated and executed in regular practice in line with national guidelines and recommendations for practice, respectively. KJD treatment uses an external fixation frame, distracting the two bony ends of the knee joint at 5mm according to prescribed procedures for six weeks (fig), with full weight-bearing allowed and encouraged. Rehabilitation is according to regular practice. Primary and secondary outcomes are pain, stiffness, physical functioning (WOMAC), quality of life (EQ-5D), adverse events and cost-effectiveness. All over 24 months.
Results
As discussed and endorsed with all stakeholders, including patient and professional associations, this study needs to demonstrate non-inferiority of KJD compared to KA with a non-inferiority limit of 15 points on the WOMAC total score.
Conclusion
This study will determine the place of knee distraction in the treatment of relatively young end-stage knee OA patients.