Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?

Shin Kong Wu Ho-Su Memorial Hospital

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: functional knee brace

Study type: Interventional

Funder types: Other

Identifiers

NCT02712710

SKH-8302-104-DR-30 (Other Grant/Funding Number)

20140714R

Details and patient eligibility

About

The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.

Full description

20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. Another 20 subjects with comparable body height, weight, and sex will be served as a control group. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week). VAS pain score, WOMAC index, and SF-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. Patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. Patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. A 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + PT and PT only) and 1 within subject factor (evaluation time:T0, T1, T2) , was performed. Pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or Mann-Whitney U test (if not in normal distribution). Investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee OA.

Enrollment: 41 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace.

Exclusion criteria

1. have undergone knee surgery
2. the lateral tibiofemoral joint severe (tibio-femoral joint) disease
3. serious knee ligament laxity
4. knee flexion contracture (flexion contracture) than 20 degrees
5. unable to walk
6. the skin of metal (aluminum) allergy
7. lower extremity vascular lesions or swelling

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

wear a functional knee brace

Experimental group

Description:

20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)

Treatment:

Device: functional knee brace

no wear a functional knee brace

No Intervention group

Description:

Another 20 subjects with comparable body height, weight, and sex. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)