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nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

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: NCT03182374
Recruitment Status : Active, not recruiting
First Posted : June 9, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE June 6, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE July 14, 2017
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections [ Time Frame: 12 months ]
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • NRS pain scale [ Time Frame: 12 months ]
    Change in pain as measured by NRS pain scale
  • OMERACT-OARSI [ Time Frame: 12 months ]
    Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria
  • WOMAC LK 3.1 [ Time Frame: 12 months ]
    Change in WOMAC LK 3.1 function, stiffness subscale and overall scores
  • EQ-5D [ Time Frame: 12 months ]
    Change in quality of life
  • Adverse Events (AEs) [ Time Frame: 12 months ]
    Occurrence of AEs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis
Official Title  ICMJE A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis
Brief Summary This is a two-phase multicenter, double-blind, randomized, prospective evaluation of intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum study duration for each subject will be 62 months; 60 months from treatment to last follow-up, and two additional months if the maximum visit window is realized. A total of 246 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria, but can be generally characterized as patients with painful unilateral knee OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
During the long-term follow-up phase (12 - 60 months), subjects may also elect to cross over to the other treatment arm and receive additional injections of the other treatment as frequently as needed, provided they did not experience any significant clinical concerns after previous treatment administrations and are benefiting from it, as determined by the investigator. Subjects may only cross over from their originally assigned treatment group to the other treatment group one time during the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is a double-blind study where subjects and evaluators are blinded to treatment up to 12-months. During the long-term follow-up phase (12 - 60 months), only subjects will be blinded to the study treatment resulting in single-blind design following 12-month follow-up time point.
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Device: nSTRIDE APS
    Intra-articular injection
    Other Name: Autologous Protein Solution
  • Device: Synvisc-One
    Intra-articular injection
    Other Name: hylan G-F 20
Study Arms  ICMJE
  • Active Comparator: nSTRIDE APS
    The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms.
    Intervention: Device: nSTRIDE APS
  • Active Comparator: Synvisc-One
    Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee
    Intervention: Device: Synvisc-One
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
246
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female at least 18 years of age at time of screening.
  • Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
  • A standing knee radiograph showing a K-L grade of 2 to 4
  • Body mass index ≤ 40 kg/m2
  • A qualifying WOMAC LK 3.1 pain subscale total score
  • Signed an ethics committee-reviewed and approved informed consent form.

Exclusion Criteria:

  • Presence of clinically observed active infection in the index knee
  • Presence of symptomatic OA in the non-study knee at screening
  • 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
  • Presence of venous or lymphatic stasis in the index leg
  • A history of local anesthetic allergy
  • Previously documented failed treatment with nSTRIDE APS or Synvisc One
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Belgium,   Denmark,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03182374
Other Study ID Numbers  ICMJE APSS-66-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: 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: Elizaveta Kon Humanitas University Hospital
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