Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- OAD Orthopaedics
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Reduction in knee pain
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Viscosupplementation injections
Control group will receive a series of three viscosupplementation injections into the affected knee
Intervention: Orthovisc (Other)
Off-loading knee brace
Intervention: DonJoy HA lite knee brace (Device)
Viscosupplementation and knee brace
Intervention: Orthovisc injections and DonJoy HA lite knee brace (Device)
Outcomes
Primary Outcomes
Reduction in knee pain
Time Frame: 3 months
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.
Secondary Outcomes
No secondary outcomes reported