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

NCT ID: NCT02712710

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Keywords

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knee, osteoarthritis, brace

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wear a functional knee brace

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)

Group Type EXPERIMENTAL

functional knee brace

Intervention Type DEVICE

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

no wear a functional knee brace

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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functional knee brace

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin-Fen Hsieh, M.D

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 31204145 (View on PubMed)

Other Identifiers

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SKH-8302-104-DR-30

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20140714R

Identifier Type: -

Identifier Source: org_study_id