|- candidate number||27494|
|- NTR Number||NTR6556|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jul-2017|
|- Secondary IDs||NL58294.099 CCMO|
|- Public Title||Orthosis for treatment of Knee Osteoarthritis|
|- Scientific Title||Feasibility study of an orthosis for treatment of Osteoarthritis|
|- hypothesis||The hypothesis is that this load-reducing orthosis will result in reduction of symptoms and regeneration of cartilage in an osteoarthritic knee joint.|
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Gonarthrose|
|- Inclusion criteria||• age between 25 and 60 years|
• primary unilateral osteoarthritis in the tibiofemoral joint
• severity of osteoarthritis: moderate to severe (KL2 or higher) but below the level required for joint replacement
|- Exclusion criteria||• osteoarthritis in both knees|
• generalized osteoarthritis (genetic)
• mechanical axis deviations > 10°
• psychological problems that would hinder wearing the orthosis
• primary retro patellar osteoarthritis
• BMI ≥ 30
• Balance problems (ASA 3 or higher)
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-aug-2017|
|- planned closingdate||1-feb-2021|
|- Target number of participants||10|
|- Interventions||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).
|- Primary outcome||The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy et al. 1988), an osteoarthritis specific questionnaire for pain, stiffness and functioning between pre-intervention and after 24 months.|
|- Secondary outcome||Secondary outcomes are: |
- the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy et al. 1988) between all other time-points.
- Visual Analogue Scale (VAS) scores for pain (Bijur et al, 2001; Downie et al, 1978) between all time-points.
- assessment of articular cartilage volume with MRI (using the GENERIC protocol) between all time-points.
- severity of osteoarthritis determined with standardized knee X-rays between all time-points
|- Timepoints||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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| M.R. Huizinga|
|- CONTACT for SCIENTIFIC QUERIES|| M.R. Huizinga|
|- Sponsor/Initiator ||Martini Hospital Groningen, Department of Orthopedics|
(Source(s) of Monetary or Material Support)
|D.H. Heijne Stichting, OIM orthopedie|
|- Brief summary||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. |
|- Main changes (audit trail)|
|- RECORD||4-jul-2017 - 29-jul-2017|