Orthosis for treatment of Knee Osteoarthritis

Recent studies have shown that regeneration might occur in osteoarthritis of the knee by using a joint distraction procedure in combination with joint mobility. This procedure provides both time and opportunity for self-healing by preventing mechanical loading and allowing nutrition transport to the cartilage. The current invasive method has a high potential for infection. We hypothesize, that the use of a knee orthosis that allows knee mobility but unloads the joint, will result in reduction of symptoms and regeneration of an osteoarthritic knee joint. The aim of this study is to test a load-reducing leg orthosis for treatment of osteoarthritis on functioning, pain, severity of knee osteoarthritis and safety of the device.

The hypothesis is that this load-reducing orthosis will result in reduction of symptoms and regeneration of cartilage in an osteoarthritic knee joint.

T0: start orthosis use, visit orthopedic surgeon, questionnaires, X-ray and MRI.

T1: 2 months (end using orthosis), questionnaires and X-ray

T2: 6 months, visit orthopedic surgeon, questionnaires and X-rays.

T3: 12 months, visit orthopedic surgeon, questionnaires, X-rays and MRI.

T4: 18 months, questionnaires and X-rays

T5: 24 months, visit orthopedic surgeon, questionnaires, X-rays and MRI.

During the T0 measurement patients fill out the VAS and WOMAC questionnaires and both a X-ray and MRI are performed. After this visit participants can start with the intervention that will last for two months. On forehand, patients will go to the OIM for two or three fittings (approximately 30 minutes per visit), after which the orthosis will be ready for use.



During the two month intervention period, where participants wear the orthosis, they have to fill out a log every day. In this log they have to document whether they wear the orthosis or not and if they experience problems with the orthosis and whether their symptoms change. They are also asked to document their pain killer use in the log.



After 2 months (end of intervention period), 6 months and 18 months patients will visit the hospital again for the VAS and WOMAC and X-ray. At 12 and 24 months in addition a MRI will be performed. During visits T0 (start of intervention), 3 months (additional control visit), T2 (6 months), T3 (12 months) and T7 (24 months) patients also visit the orthopaedic surgeon (part of usual care).