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Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Zimmer Biomet
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT02905240
First received: September 14, 2016
Last updated: March 28, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Osteoarthritis
Device: nSTRIDE APS
Device: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale [ Time Frame: 12 months ]
    Pain scores measured utilizing patient surveys


Secondary Outcome Measures:
  • Visual Analog Scale (VAS) Pain [ Time Frame: 12 months ]
    Change in pain as measured by VAS pain

  • Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders [ Time Frame: 12 months ]
    Percentage of OMERACT-OARSI responders

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale [ Time Frame: 12 months ]
    Stiffness scores measured utilizing patient surveys

  • Quality of Life [ Time Frame: 12 months ]
    Change in quality of life utilizing patient surveys

  • Adverse Events [ Time Frame: 12 months ]
    Frequency of adverse events of interest


Estimated Enrollment: 246
Study Start Date: November 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nSTRIDE APS
Autologous Protein Solution prepared using the nSTRIDE APS Kit
Device: nSTRIDE APS
single intra-articular injection
Other Name: Autologous Protein Solution
Saline
Saline control
Device: Saline
single intra-articular injection
Other Name: Saline control

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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02905240

Contacts
Contact: Kim Rowe, M.S. (574) 372-1966 kimberly.rowe@zimmerbiomet.com
Contact: Krista Toler, M.S., MBA (574)371-3812 krista.toler@zimmerbiomet.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Stephanie Biggers, RN    205-934-1444    sbiggers@uabmc.edu   
Principal Investigator: Jasvinder Singh, MD         
United States, Arizona
Tucson Orthopaedic Institute, PC Recruiting
Tucson, Arizona, United States, 85712
Contact: Yvonne Ruiz    520-784-6481    yruiz@tucsonortho.com   
Contact: Jelena Candito       jcandito@tucsonortho.com   
Principal Investigator: Nebojsa Skrepnik, MD,         
United States, Florida
Andrews Research and Education Foundation (AREF) Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Laura Schubert, RN    850-916-8581    laura.schubert@andrewsref.org   
Contact: Cassidy Shefford, MBA    (850) 916-8592    cassidy.shefferd@andrewsref.org   
Principal Investigator: Brett Kindle, M.D.         
Florida Hospital Orthopaedic Institute and Fracture Care Center Recruiting
Orlando, Florida, United States, 32804
Contact: Susan Nelson    407-303-1339    susan.nelson@flhosp.org   
Principal Investigator: J. Dean Cole, MD         
United States, Illinois
Rockford Orthopedic Associates, Ltd Recruiting
Rockford, Illinois, United States, 61114
Contact: Catherine Mariano    815-484-6942    catherine.marinaro@orthoillinois.com   
Contact: Lisa Foti    (320) 360-0859    lisa.foti@orthoillinois.com   
Principal Investigator: Michael Chmell, MD         
United States, Indiana
Orthopedic & Sports Medicine Center Recruiting
Elkhart, Indiana, United States, 46514
Contact: Kelly Ganz    574-264-0791    kganz@osmc.com   
Principal Investigator: Jason Hix, MD         
OrthoIndy Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki Snodgrass Miller, BA    317-884-5230    vsmiller@orthoindy.com   
Principal Investigator: Jack Farr, MD         
United States, Kansas
Kansas University Medical Center Research Institute, Inc. Recruiting
Kansas City, Kansas, United States, 66160
Contact: Dawn Lockhart    913-945-6196    dlockhart@kumc.edu   
Principal Investigator: Neil Segal, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Amy Phan    617-732-4070    atphan@partners.org   
Principal Investigator: Andreas Gomoll, MD         
United States, New York
Northwell Health - Great Neck Recruiting
Great Neck, New York, United States, 11021
Contact: Marlena McGill    718-470-7320    mmcgill@northwell.edu   
Principal Investigator: Nicholas Sgaglione, MD         
Northwell Health - Lenox Hill Recruiting
New York, New York, United States, 10065
Contact: Vivian Papas    212-434-4340    ppapas@northwell.edu   
Sub-Investigator: Giles Scuderi, MD         
Sub-Investigator: Fred Cushner, MD         
Principal Investigator: Nicholas Sgaglione, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Angela Pedroza    614-293-7952    angela.pedroza@osumc.edu   
Principal Investigator: Robert Magnussen, MD         
Joint Implant Surgeons, Inc Recruiting
New Albany, Ohio, United States, 43054
Contact: Michael Sneller    614-221-6331 ext 347    snellerMA@joint-surgeons.com   
Principal Investigator: Jason Hurst, MD         
United States, Tennessee
The Campbell Foundation Recruiting
Germantown, Tennessee, United States, 38138
Contact: Margaret Knack, RN, MS, CCRP    901-759-5413    mknack@campbell-foundation.org   
Principal Investigator: Santos F. Martinez, M.D.         
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Frederick M Azar, M.D. Campbell Clinic Orthopaedics
  More Information

Publications:
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02905240     History of Changes
Other Study ID Numbers: APSS-44-00
Study First Received: September 14, 2016
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Zimmer Biomet:
Autologous Protein Solution
APS
intra-articular injection
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 23, 2017