Clinical trial NCT02712710: Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
Official title: Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee, osteoarthritis, brace
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS pain score
timeFrame: 1 month
Secondary outcomes:
measure: WOMAC index
timeFrame: 1 month
measure: SF-36
timeFrame: 1 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh LF, Lin YT, Wang CP, Liu YF, Tsai CT. Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian patients with medial compartment knee osteoarthritis-A preliminary report. J Formos Med Assoc. 2020 Jan;119(1 Pt 2):319-326. doi: 10.1016/j.jfma.2019.05.024. Epub 2019 Jun 13.