Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02905240

Run by

Zimmer Biomet

People needed

332

Starts

2016-11-01

Expected to finish

2020-06-01

Last updated by the study team

2023-11-07

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 21 and ≤ 80 years old at the time of screening
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions
• A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis
• Body Mass Index ≤ 40
• A qualifying WOMAC LK 3.1 pain subscale total score
• Has undergone at least one prior conservative osteoarthritis treatment
• Signed an institutional review board approved informed consent

You may not qualify if…

• Presence of clinically observed active infection in the index knee
• Presence of symptomatic osteoarthritis in the non-study knee
• Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
• Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
• Untreated symptomatic injury of the index knee
• Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee
• Previous cartilage repair procedure on the injured cartilage surface of the index knee
• Arthroplasty or open surgery of the index knee within 6 months of screening
• Intra-articular steroid injection in the index knee within 3 months of screening
• Intra-articular hyaluronic acid injection in the index knee within 6 months of screening
• Other intra-articular therapy in the index knee within 6 months prior to screening
• Orally administered systemic steroid use within 2 weeks of screening
• Planned/anticipated surgery of the index knee during the study period
• Skin breakdown at the knee where the injection is planned to take place
• Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
• Participated in any investigational drug or device trial within 30 days prior to screening
• Participated in any investigational biologic trial within 60 days prior to screening

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• AVANT Research Associates, LLC — Guntersville, Alabama, United States
• Tucson Orthopaedic Institute, PC — Tucson, Arizona, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Andrews Research and Education Foundation (AREF) — Gulf Breeze, Florida, United States
• Florida Hospital Orthopaedic Institute and Fracture Care Center — Orlando, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Orthoillinois, Ltd. — Rockford, Illinois, United States
• Orthopedic & Sports Medicine Center — Elkhart, Indiana, United States
• OrthoIndy — Greenwood, Indiana, United States
• Kansas University Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• Brigham and Women's Mass General Health Care Center — Foxborough, Massachusetts, United States
• Northwell Health - Great Neck — Great Neck, New York, United States
• Northwell Health - Lenox Hill — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Joint Implant Surgeons, Inc — New Albany, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The Campbell Foundation — Germantown, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Texas Center for Joint Replacement — Plano, Texas, United States

Full record on ClinicalTrials.gov

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