Treatment of Knee Osteoarthritis With PAAG-OA
NCT04045431 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238
Last updated 2024-01-08
Summary
This is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (PAAG-OA) and a hyaluronic acid, Synvisc-One to induce symptomatic benefit in subjects with knee osteoarthritis.
Conditions
- Osteoarthritis, Knee
Interventions
- DEVICE
-
PAAG-OA
Intra-articular injection of 6ml PAAG-OA in the target knee (incl. five (5) years follow-up) period.
- DEVICE
-
Synvisc-One
Intra-articular injection of 6ml Synvisc-One in the target knee
Sponsors & Collaborators
-
Contura
lead INDUSTRY
Principal Investigators
-
Henning Bliddal, MD · The Parker Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-15
- Primary Completion
- 2020-10-01
- Completion
- 2026-11-30
Countries
- Denmark
Study Locations
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