Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
NCT02905240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332
Last updated 2023-11-07
Summary
A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.
Conditions
Interventions
- DEVICE
-
nSTRIDE APS
single intra-articular injection
- DEVICE
-
Saline
single intra-articular injection
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Frederick M Azar, M.D. · Campbell Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2019-07-31
- Completion
- 2020-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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