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

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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.


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
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Boulder, CO
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Beverly Hills, California 90211
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Charleston, South Carolina 29412
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Duncansville, Pennsylvania 16635
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Lauderdale Lakes, Florida 33313
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