Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Osteoarthritis

Interventions: Device: nSTRIDE APS
Device: Saline

Registration Number: NCT02905240

Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed Description: A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 332

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nSTRIDE APS	nSTRIDE APS	Autologous Protein Solution prepared using the nSTRIDE APS Kit
Saline	Saline	Saline control

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months	Baseline and 12 Months	The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 months	Subjects experiencing at least one AE
EQ-5D Change From Baseline to 12 Months	Baseline and 12 Months	The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months	Baseline and 12 Months	The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months	Baseline and 12 Months	The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).
Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders	12 months	The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of ≥50% and absolute change ≥20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment).

Trial Locations

Locations (27): CORE Orthopaedic Medical Center
🇺🇸
Encinitas, California, United States
Florida Hospital Orthopaedic Institute and Fracture Care Center
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Orlando, Florida, United States
Andrews Research and Education Foundation (AREF)
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Gulf Breeze, Florida, United States
Orthoillinois, Ltd.
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Rockford, Illinois, United States
Joint Implant Surgeons, Inc
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New Albany, Ohio, United States
Northwell Health - Lenox Hill
🇺🇸
New York, New York, United States
Brigham and Women's Mass General Health Care Center
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Foxboro, Massachusetts, United States
AVANT Research Associates, LLC
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Guntersville, Alabama, United States
Northwell Health - Great Neck
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Great Neck, New York, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
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Houston, Texas, United States
University of California at Los Angeles
🇺🇸
Los Angeles, California, United States
Comprehensive Clinical Trials, LLC
🇺🇸
West Palm Beach, Florida, United States
University of Cincinnati College of Medicine
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Cincinnati, Ohio, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Orthopedic & Sports Medicine Center
🇺🇸
Elkhart, Indiana, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Kansas University Medical Center Research Institute, Inc.
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Kansas City, Kansas, United States
University of Alabama
🇺🇸
Birmingham, Alabama, United States
OrthoIndy
🇺🇸
Greenwood, Indiana, United States
Tucson Orthopaedic Institute, PC
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Tucson, Arizona, United States
Texas Center for Joint Replacement
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Plano, Texas, United States
Wake Forest School of Medicine
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Winston-Salem, North Carolina, United States
OrthoVirginia
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Richmond, Virginia, United States
University of Virginia
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Charlottesville, Virginia, United States
University of California, San Francisco
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San Francisco, California, United States
The Campbell Foundation
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Germantown, Tennessee, United States