Valgus bracing, unicompartmental osteoarhritis, varus knee, RCT
Conditions
Interventions
Trial arm 1: 3 months prescription of the Bledsoe Thruster Brace.
Trial arm 2: 3 months prescription of the SofTec OA Brace.
Sponsors
Maatschap orthopaedie ziekenhuis Rijnstate
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the VAS pain score at 3 months between the Bledsoe Thruster group and the SofTec OA Brace group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactS. Grinsven, van
Wagnerlaan 55
Outcome results
None listed