Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

NCT02905240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2023-11-07

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02905240 on ClinicalTrials.gov