Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 1/1/2014 |
| Start Date: | December 2012 |
| Contact: | Melanie Bammert |
| Email: | melanie.bammert@aptivsolutions.com |
| Phone: | +1 919 724 6947 |
A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee
The purpose of the study is to determine whether a single intra-articular injection of
Durolane is superior to a single injection of PBS for the relief of joint pain in patients
with osteoarthritis of the knee.
Durolane is superior to a single injection of PBS for the relief of joint pain in patients
with osteoarthritis of the knee.
Inclusion Criteria:
- Body Mass Index (BMI) ≤ 35 kg/m2
- Symptomatic OA of the knee
- K L severity grade 1 or 2
- If bilateral OA, contralateral knee K L severity grade 0 or 1
Exclusion Criteria:
- Has clinically apparent tense effusion of the index knee
- Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy
in the index knee in the past 3 months
- Has any painful orthopedic disorders of the back or hip
- Has a joint disorder other than osteoarthritis in the index knee
We found this trial at
25
sites
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