De effectiviteit van een kniebrace in de behandeling van artrose van de knie: een gerandomiseerde klinische studie.
- Conditions
- valgus bracing / valgus bracingmedial compartment / mediale compartimentosteoarthritis / osteoarthitisvarus knee / varus knie
- Registration Number
- NL-OMON20677
- Lead Sponsor
- Bauerfeind AGTriebeser Strasse 1607937 Zeulenroda-TriebesGermany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Patients with medial knee osteoarthritis (confirmed on X-ray (AP and lateral using the Kellgren classification.
Medial knee pain.
Exclusion Criteria
Insufficient command of the Dutch language.
The inability to apply a 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 6 months between the Bauerfeind SecuTec OA brace and controls receiving only conservative treatment.
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale pain, VAS satisfaction, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the SF-12 and the 6-Minutes Walking Test at baseline, 2 weeks, 3 and 6 months. Patients need to keep a diary once a week during the 6 months of participation (24 weeks). In the brace group, patients record their analgesic usage, physical therapy usage, compliance and adverse events. In the control group, analgesic usage and physical therapy usage are recorded.