De effectiviteit van een kniebrace in de behandeling van artrose van de knie: een gerandomiseerde klinische studie.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20677

Enrollment

Registered

2018-08-22

Start date

2018-10-22

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

valgus bracing / valgus bracing medial compartment / mediale compartiment osteoarthritis / osteoarthitis varus knee / varus knie

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

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.	—

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.

—

Contacts

Public ContactS. Grinsven, van

Wagnerlaan 55

SvanGrinsven@Alysis.nl+31 (0)88 0056366

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)