|- candidate number||8233|
|- NTR Number||NTR2428|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jul-2010|
|- Secondary IDs||2010/200 CCMO|
|- Public Title||Valgus bracing.|
|- Scientific Title||The effectiveness of two different valgus braces in the treatment of varus medial compartment osteoarthritis of the knee: A randomized clinical trial.|
|- hypothesis||Our primary objective is to compare the short term (3 months) clinical and radiographic results of the Bledsoe Thruster with the SofTec OA Brace in the management of patients with medial knee OA and a varus leg alignment.|
|- Healt Condition(s) or Problem(s) studied||Valgus bracing, Unicompartmental osteoarhritis, Varus knee|
|- Inclusion criteria||1. Patients with medial knee osteoarthritis (confirmed on x-ray (AP and lateral) using the Kellgren classification);
2. Medial knee pain;|
3. Varus leg alignment (confirmed on X-ray);
4. Age between 18-70.
|- Exclusion criteria||1. Insufficient command of the Dutch language;|
2. The inability to apply brace because of physical or cognitive limitations;
3. Symptomatic back/hip/ankle/foot pathology (which makes improvement of pain, function, quality of life and satisfaction, by wearing a brace, impossible);
4. Other than osteoarthritis causing knee pain (like arthritis);
5. Pre-existing skin problems.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2010|
|- planned closingdate||31-dec-2012|
|- Target number of participants||80|
|- Interventions||Trial arm 1: 3 months prescription of the Bledsoe Thruster Brace.|
Trial arm 2: 3 months prescription of the SofTec OA Brace.
|- Primary outcome||Difference in the VAS pain score at 3 months between the Bledsoe Thruster group and the SofTec OA Brace group.|
|- Secondary outcome||1. Visual Analogue Scale for pain and satisfacion (VAS-pain, VAS-satisfaction);|
2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);
3. The SF-12 and the 6-Minutes Walking.
Test at baseline, 2 weeks and 3 months. Radiographs of varus leg alignment at baseline without brace and at 3 months with brace. Patients need to keep a diary once a week during the 3 months of participation. In this diary they record mean daily analgesics use, complications and compliance.
|- Timepoints||Baseline, 2 weeks and 3 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| S. Grinsven, van|
|- CONTACT for SCIENTIFIC QUERIES|| C.J.M. Loon, van|
|- Sponsor/Initiator ||Rijnstate Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Bauerfeind Benelux B.V., B&Co INC NV|
|- Brief summary||Background of the study:|
Knee osteoarthritis (OA) is one of the most common joint disorders and is a major cause of knee pain and immobility. Treatment can be non-operative or operative. Operative treatment is not suitable for every patient, because of medical comorbidity, old age or other circumstances. In young patients it is desirable to delay primary arthroplasty. Osteoarthritis of the knee is more located in the medial compartment. Patients with OA of the medial compartment also often have a varus alignment and the varus deformity causes an overlaoad of the medial compartment with increasing symptoms during weight bearing. malalignment increases risk for progression of knee OA. Valgus braces are designed to unlaod the medial compartment in order to decrease pain and improve function. Recent systematic reviews concluded that there is very limited evidence for the effectiveness of brace treatment for medial knee osteoarthritis, mainly because of lack of randomized clinical trials. More than 30 commercially available braces are produced nowadays, with al kind of different brace designs. To our knowledge no study has compared the effectiveness of two different kind of braces as treatment of medial knee OA in a randomized clinical trial.
|- Main changes (audit trail)|
|- RECORD||13-jul-2010 - 3-okt-2010|