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

The effectiveness of a valgus brace in the treatment of varus medial compartment osteoarthritis of the knee: a randomized clinical trial - SecuTec OA brace versus no brace

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52722

Enrollment

Registered

2019-01-15

Start date

2019-03-07

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arthrosis of the knee Gonarthrosis

Interventions

Group 1: 6 months prescription of the Bauerfeind SecuTec OA brace in combination with the standard conservative treatment containing of education and analgetics / physical therapy if needed. Group 2

Eligibility

Age

18 Years to 64 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 40-70.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Difference in the VAS pain score at 6 months between the Bauerfeind SecuTec OA brace and controls receiving only conservative treatment.	—

Secondary

Measure	Time frame
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. After the final 6-month measurement, patients from the intervention group (1) will be invited to undergo a 30-minute in-depth semi-structured interview focussing on their perceptions about the (use of the) brace.	—

Measure

Time frame

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. After the final 6-month measurement, patients from the intervention group (1) will be invited to undergo a 30-minute in-depth semi-structured interview focussing on their perceptions about the (use of the) brace.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)