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

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

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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Valgus knee brace (Medex K39-OA Corrector)
* Other: Physiotherapy and oral analgesic (diclofenac and panadol)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee brace group<br>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). | Device: Valgus knee brace (Medex K39-OA Corrector)<br>* Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.<br>Other: Physiotherapy and oral analgesic (diclofenac and panadol)<br>* Physiotherapy and oral analgesic (diclofenac and panadol)<br>|
| Active Comparator: Control Group<br>Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol). | Other: Physiotherapy and oral analgesic (diclofenac and panadol)<br>* Physiotherapy and oral analgesic (diclofenac and panadol)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain | Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control | At 16 weeks after the initiation of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in knee functioning | The Western Ontario and McMaster Universities Osteoarthritis Index | At 16 weeks after the initiation of the study |