Valgus bracing.
- Conditions
- Valgus bracing, unicompartmental osteoarhritis, varus knee, RCT
- Registration Number
- NL-OMON26399
- Lead Sponsor
- Maatschap orthopaedie ziekenhuis Rijnstate
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Patients with medial knee osteoarthritis (confirmed on x-ray (AP and lateral) using the Kellgren classification);
2. Medial knee pain;
Exclusion Criteria
1. Insufficient command of the Dutch language;
2. The inability to apply brace because of physical or cognitive limitations;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the VAS pain score at 3 months between the Bledsoe Thruster group and the SofTec OA Brace group.
- Secondary Outcome Measures
Name Time Method 1. Visual Analogue Scale for pain and satisfacion (VAS-pain, VAS-satisfaction);<br /><br>2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);<br /><br>3. The SF-12 and the 6-Minutes Walking.<br><br /><br /><br>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.