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Trial record 1 of 1168 for:    progress IV
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Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905240
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date January 10, 2020
Study Start Date  ICMJE November 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale [ Time Frame: 12 months ]
Pain scores measured utilizing patient surveys
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • 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
  • EQ-5D [ Time Frame: 12 months ]
    Change in quality of life utilizing patient surveys
  • Adverse Events [ Time Frame: 12 months ]
    Frequency of adverse events of interest
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Official Title  ICMJE A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Device: nSTRIDE APS
    single intra-articular injection
    Other Name: Autologous Protein Solution
  • Device: Saline
    single intra-articular injection
    Other Name: Saline control
Study Arms  ICMJE
  • Experimental: nSTRIDE APS
    Autologous Protein Solution prepared using the nSTRIDE APS Kit
    Intervention: Device: nSTRIDE APS
  • Saline
    Saline control
    Intervention: Device: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
332
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905240
Other Study ID Numbers  ICMJE APSS-44-00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederick M Azar, M.D. Campbell Clinic
PRS Account Zimmer Biomet
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP