The effectiveness of a valgus brace in the treatment of varus medial compartment osteoarthritis of the knee: a randomized clinical trial

Completed

Conditions: arthrosis of the knee
Gonarthrosis
10023213

Registration Number: NL-OMON52722

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.
Varus leg alignment (confirmed on X-ray)
Age between 40-70.

Exclusion Criteria

Insufficient command of the Dutch language.
The inability to apply a 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.
OA confirmed Kellgren classification grade I or IV.
Systemic disease influencing the musculoskeletal system including among others
rheumatoid arthritis, fibromyalgia and systemic lupus erythematosus.
Body mass index above 35.
Distinct patellofemoral osteoarthritis.
Intra-articular injection with glucocorticosteroids combined with analgesics
within 3 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in the VAS pain score at 6 months between the Bauerfeind SecuTec OA<br /><br>brace and controls receiving only conservative treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Visual Analogue Scale pain, VAS satisfaction, the Western Ontario and McMaster<br /><br>Universities Osteoarthritis Index (WOMAC), the SF-12 and the 6-Minutes Walking<br /><br>Test at baseline, 2 weeks, 3 and 6 months. Patients need to keep a diary once a<br /><br>week during the 6 months of participation (24 weeks). In the brace group,<br /><br>patients record their analgesic usage, physical therapy usage, compliance and<br /><br>adverse events. In the control group, analgesic usage and physical therapy<br /><br>usage are recorded. After the final 6-month measurement, patients from the<br /><br>intervention group (1) will be invited to undergo a 30-minute in-depth<br /><br>semi-structured interview focussing on their perceptions about the (use of the)<br /><br>brace.</p><br>