Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
NCT ID: NCT02905240
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
332 participants
INTERVENTIONAL
2016-11-30
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nSTRIDE APS
Autologous Protein Solution prepared using the nSTRIDE APS Kit
nSTRIDE APS
single intra-articular injection
Saline
Saline control
Saline
single intra-articular injection
Interventions
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nSTRIDE APS
single intra-articular injection
Saline
single intra-articular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
80 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Frederick M Azar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Campbell Clinic
Locations
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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
University of Virginia
Charlottesville, Virginia, United States
OrthoVirginia
Richmond, Virginia, United States
Countries
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References
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King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9.
van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APSS-44-00
Identifier Type: -
Identifier Source: org_study_id
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