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nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Sponsor
Zimmer Biomet (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03182374
Collaborator
(none)
246
Enrollment
14
Locations
2
Arms
74.5
Anticipated Duration (Months)
17.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: nSTRIDE APS
  • Device: Synvisc-One
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
246 participants
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.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
Official Title:
A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis
Actual Study Start Date :
Jul 14, 2017
Actual Primary Completion Date :
Sep 30, 2019
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Device: nSTRIDE APS
Intra-articular injection
Other Names:
  • Autologous Protein Solution

    		•
    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

    Device: Synvisc-One
    Intra-articular injection
    Other Names:
  • hylan G-F 20

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections [12 months]

      Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score

    Secondary Outcome Measures

    1. NRS pain scale [12 months]

      Change in pain as measured by NRS pain scale

    2. OMERACT-OARSI [12 months]

      Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria

    3. WOMAC LK 3.1 [12 months]

      Change in WOMAC LK 3.1 function, stiffness subscale and overall scores

    4. EQ-5D [12 months]

      Change in quality of life

    5. Adverse Events (AEs) [12 months]

      Occurrence of AEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AZ Monica Antwerp Belgium
    2 The Parker Institute, Frederiksberg Hospital Copenhagen Denmark
    3 Praxiskliniek für Unfallchirurgie und Orthopädie Eisenach Germany
    4 KniePraxis Straubing Germany
    5 Rizzoli Orthopedic Institute Bologna Italy
    6 The Istituto Clinico Humanitas Milano Italy
    7 Maastricht UMC+ Maastricht Netherlands
    8 Oslo University Hospital - Olympiatoppen Oslo Norway
    9 Hospital Clínic de Barcelona Barcelona Spain
    10 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain
    11 Ospedale Regionale di Lugano Lugano Switzerland
    12 Yildirim Beyazit University, School of Medicine Ankara Turkey
    13 Gloucestershire Hospitals NHS Foundation Trust Cheltenham United Kingdom
    14 Royal Infirmary of Edinburgh - NHS Lothian Edinburgh United Kingdom

    Sponsors and Collaborators

    • Zimmer Biomet

    Investigators

    • Principal Investigator: Elizaveta Kon, Humanitas University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT03182374
    Other Study ID Numbers:
    • APSS-66-00
    First Posted:
    Jun 9, 2017
    Last Update Posted:
    Jan 22, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Zimmer Biomet
    Autologous Protein Solution (APS)
    Intra-articular Injection
    Osteoarthritis
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Hylan

    Study Results

    No Results Posted as of Jan 22, 2020