Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

NCT02905240 | Completed Results DMC FDA Device

• 1 other identifier: APSS-44-00
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 27

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.

Conditions

Osteoarthritis

Keywords

Autologous Protein Solution; APS; intra-articular injection; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 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).

  Baseline and 12 Months

Secondary Outcomes (5)

• Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months

  Baseline and 12 Months

• Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders

  12 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months

  Baseline and 12 Months

• EQ-5D Change From Baseline to 12 Months

  Baseline and 12 Months

• Adverse Events

  12 months

Study Arms (2)

nSTRIDE APS

EXPERIMENTAL

Autologous Protein Solution prepared using the nSTRIDE APS Kit

Device: nSTRIDE APS

Saline

OTHER

Saline control

Device: Saline

Interventions

nSTRIDE APS DEVICE

single intra-articular injection

Also known as: Autologous Protein Solution

nSTRIDE APS

Saline DEVICE

single intra-articular injection

Saline

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (27)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

AVANT Research Associates, LLC

Guntersville, Alabama, 35976, United States

Location

Tucson Orthopaedic Institute, PC

Tucson, Arizona, 85712, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Andrews Research and Education Foundation (AREF)

Gulf Breeze, Florida, 32561, United States

Location

Florida Hospital Orthopaedic Institute and Fracture Care Center

Orlando, Florida, 32804, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Orthoillinois, Ltd.

Rockford, Illinois, 61114, United States

Location

Orthopedic & Sports Medicine Center

Elkhart, Indiana, 46514, United States

Location

OrthoIndy

Greenwood, Indiana, 46143, United States

Location

Kansas University Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

Brigham and Women's Mass General Health Care Center

Foxborough, Massachusetts, 02035, United States

Location

Northwell Health - Great Neck

Great Neck, New York, 11021, United States

Location

Northwell Health - Lenox Hill

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45229, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Joint Implant Surgeons, Inc

New Albany, Ohio, 43054, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Campbell Foundation

Germantown, Tennessee, 38138, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Center for Joint Replacement

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

OrthoVirginia

Richmond, Virginia, 23294, United States

Location

Related Publications (2)

• 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.

  PMID: 26915009 BACKGROUND

• 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.

  PMID: 27668131 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Jennifer Woodell-May, Research Associate Director
• Organization: Zimmer Biomet

jennifer.woodell-may@zimmerbiomet.com

5742651885

Study Officials

• Frederick M Azar, M.D.

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: June 1, 2020
• Last Updated: November 7, 2023
• Results First Posted: October 19, 2023

Record last verified: 2023-10

Locations

US (27)