Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-06-30

Brief Summary

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To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.

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Detailed Description

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Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.

Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.

Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.

Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Outcome assessors are blinded from the treatment received

Study Groups

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Knee brace group

Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol).

Group Type EXPERIMENTAL

Valgus knee brace (Medex K39-OA Corrector)

Intervention Type DEVICE

Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.

Physiotherapy and oral analgesic (diclofenac and panadol)

Intervention Type OTHER

Physiotherapy and oral analgesic (diclofenac and panadol)

Control Group

Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol).

Group Type ACTIVE_COMPARATOR

Physiotherapy and oral analgesic (diclofenac and panadol)

Intervention Type OTHER

Physiotherapy and oral analgesic (diclofenac and panadol)

Interventions

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Valgus knee brace (Medex K39-OA Corrector)

Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.

Intervention Type DEVICE

Physiotherapy and oral analgesic (diclofenac and panadol)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 40-80
* History of symptomatic medial unicompartmental knee osteoarthritis \> 6 months
* Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities
* Understanding of the Chinese language
* Ethnic Chinese patients

Exclusion Criteria

* Symptomatic knee osteoarthritis affecting more than one compartment
* Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint
* Significant knee effusion or soft tissue compromise preventing long-term knee brace use
* Obesity (BMI\>30)
* Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy
* Peripheral vascular disease of the lower limb

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No