arthrosis of the knee gonarthrosis
Conditions
Interventions
Intervention (if applicable): Trial arm 1: 3 month prescription of the Bledsoe
Thruster Brace. Trial arm 2: 3 month prescription of the SofTec OA Brace.
Sponsors
Alysis Zorggroep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with medial knee osteoarthritis (confirmed on X-ray (AP and lateral) using the Kellgren classification). Medial knee pain. Varus leg alignment (confirmed on X-ray). Age between 18-70.
Exclusion criteria
Exclusion criteria: Insufficient command of the Dutch language. The inability to apply brace because of physical or cognitive limitations. Symptomatic back/hip/ankle/foot pathology (which makes improvement of pain, function, quality of life and satisfaction, by wearing a brace, impossible). Other than osteoarthritis causing knee pain (like arthritis). 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 |
|---|---|
| Visual Analogue Scale for pijn and satisfactio (VAS-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 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. | — |
Countries
Netherlands
Outcome results
None listed