Knee Joint Distraction in comparison with Total Knee Prosthesis in treatment of knee osteoarthritis.

This, multi-center, randomised controlled, non-blinded prospective 2 years follow-up trial will be accomplished at the Maartenskliniek Woerden (MK-W) in collaboration with the University Medical Center Utrecht (UMCU). Patients with severe OA of the knee, whom are indicated for a TKP by a orthopaedic surgeon and meet the inclusion criteria are asked to participate. When included, patients will be randomised between TKP en KJD (2:1). Clinical outcome parameters are evaluated over time up to 2 years. Data on direct and indirect costs as well as change in quality of life are gathered by use of questionnaires. Additionally, the KJD patients are monitored for tissue structure repair. Blood and urine will be collected before and up to 2 years after surgery. Samples are used for evaluation of biochemical markers of cartilage and bone synthesis and breakdown. Moreover, at baseline and over time up to 2 years, X-ray and MRI images are evaluated for cartilage and bone changes.

The clinical effect of Knee Joint Distraction (determined by WOMAC) is not (clinically relevant) different from Total Knee Prosthesis at two years post treatment (equivalence hypothesis).

Baseline (2x), 3 and 6 weeks, 3, 6, 9, 12, 18 and 24 months follow-up.

KJD is performed according to the methodology as used in previous knee distraction studies, using 2 monotubes, one laterally and one medially. Intra-operative the tubes are distracted 2 mm. During hospitalization the frame is further distracted, 1mm a day, until in total 5 mm is reached. Distraction lasts for 6 weeks whereby fully load bearing is encouraged, with crutches for stability. After 6 weeks the frame is removed at day-care surgery.

TKP is performed as usual according to the clinical protocol.