Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone

Detailed Description
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A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.

Official Title
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Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Orthovisc
* Device: DonJoy HA lite knee brace
* Device: Orthovisc injections and DonJoy HA lite knee brace


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs. Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment. Subjects will also have a documented varus deformity. Exclusion criteria: Subjects with severe arthritis as demonstrated by radiographs. In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded. Female patients who are pregnant or breast feeding will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Viscosupplementation injections<br>Control group will receive a series of three viscosupplementation injections into the affected knee | Other: Orthovisc<br>* Subjects will receive a series of three Orthovisc injections into their affected knee<br>|
| Experimental: Off-loading knee brace<br> | Device: DonJoy HA lite knee brace<br>* Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee<br>|
| Experimental: Viscosupplementation and knee brace<br> | Device: Orthovisc injections and DonJoy HA lite knee brace<br>* Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in knee pain | The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire. | 3 months |