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

Knee Osteoarthritis Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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