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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02712710
Other study ID # 20140714R
Secondary ID SKH-8302-104-DR-
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date October 2017

Study information

Verified date January 2017
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date October 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
functional knee brace
The functional knee brace for OA can decrease abnormal varus torque by external force.

Locations

Country Name City State
Taiwan Shin Kong Wu Ho-Su Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS pain score To the severity of the pain patients experience pain in itself to make a quantitative expression, assessment methods as follows: a horizontal line 10 cm in length, with zero as the most left office, on behalf of completely pain-free; the far right of the line can imagine the most severe pain, subjects were at rest and walking, according to their degree of sense of pain marked on the straight line. Reliability of this scale up to 0.94. 1 month
Secondary WOMAC index Western Ontario McMaster University Osteoarthritis Index (WOMAC Index) is the most commonly used assessment study of knee osteoarthritis by functional scales, including pain, stiffness and function of physical activity and other three items. You can use the record score VAS (visual analog scale) or scale from 0 to 4 five scale. A total of 24 projects, of which pain part 5 projects, while the stiffness and joint function. 2 and 17 projects each. The total score of 100 points, higher scores indicate worse situation. WOMAC for assessing knee osteoarthritis has good reliability and validity. 1 month
Secondary SF-36 The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5). 1 month
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