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nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03182374
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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
Osteoarthritis, Knee Device: nSTRIDE APS Device: Synvisc-One Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : July 14, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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 Name: hylan G-F 20




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. NRS pain scale [ Time Frame: 12 months ]
    Change in pain as measured by NRS pain scale

  2. OMERACT-OARSI [ Time Frame: 12 months ]
    Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria

  3. WOMAC LK 3.1 [ Time Frame: 12 months ]
    Change in WOMAC LK 3.1 function, stiffness subscale and overall scores

  4. EQ-5D [ Time Frame: 12 months ]
    Change in quality of life

  5. Adverse Events (AEs) [ Time Frame: 12 months ]
    Occurrence of AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182374


Contacts
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Contact: Cahit Akbas +31622981737 cahit.akbas@zimmerbiomet.com

Locations
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Belgium
AZ Monica Recruiting
Antwerp, Belgium
Contact: Kristien Vuylsteke       morefoundation@azmonica.be   
Principal Investigator: Peter Verdonk, PhD, MD         
Denmark
The Parker Institute, Frederiksberg Hospital Recruiting
Copenhagen, Denmark
Contact: Louise Louise         
Principal Investigator: Henning Bliddal, MD, PhD         
Germany
Praxiskliniek für Unfallchirurgie und Orthopädie Recruiting
Eisenach, Germany
Contact: Gunther Spahn       spahn@pk-eisenach.de   
Principal Investigator: Gunther Spahn, MD, PhD         
KniePraxis Recruiting
Straubing, Germany
Contact: Carsten O. Tibesku       carsten@tibesku.de   
Principal Investigator: Carsten O. Tibesku, MD, PhD         
Italy
Rizzoli Orthopedic Institute Recruiting
Bologna, Italy
Contact: Frederica Balboni       f.balboni@biomec.ior.it   
Principal Investigator: Stefano Zaffagnini, MD, PhD         
The Istituto Clinico Humanitas Recruiting
Milano, Italy
Contact: Laura Lovato       lauralovato@hotmail.it   
Principal Investigator: Elizaveta Kon, MD, PhD         
Netherlands
Maastricht UMC+ Recruiting
Maastricht, Netherlands
Contact: Elisabeth Jutten - Brouwer       l.jutten@mumc.nl   
Principal Investigator: Peter Emans, MD         
Norway
Oslo University Hospital - Olympiatoppen Recruiting
Oslo, Norway
Contact: Berit Lian Berntzen       BeritLian.Berntzen@olympiatoppen.no   
Principal Investigator: Lars Engebretsen, MD, PhD         
Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain
Contact: Sergei Sastre       ssastre@clinic.ub.es   
Principal Investigator: Sergei Sastre, MD         
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Madrid, Spain
Contact: Pablo De la Cuadra       pablodelacuadra@hotmail.com   
Principal Investigator: Pablo De La Cuadra Virgili, MD, PhD         
Switzerland
Ospedale Regionale di Lugano Recruiting
Lugano, Switzerland
Contact: Christian Candrian       Christian.Candrian@eoc.ch   
Principal Investigator: Christian Candrian, MD         
Turkey
Yildirim Beyazit University, School of Medicine Recruiting
Ankara, Turkey
Contact: Safa Gursoy       safagursoy@yahoo.com   
Principal Investigator: Murat Bozkurt, MD, PhD         
United Kingdom
Gloucestershire Hospitals NHS Foundation Trust Recruiting
Cheltenham, United Kingdom
Contact: Susan Beames       susan.beames@nhs.net   
Principal Investigator: Navraj Atwal, MD         
Royal Infirmary of Edinburgh - NHS Lothian Recruiting
Edinburgh, United Kingdom
Contact: Anish Amin       Anish.Amin@nhs.net   
Principal Investigator: Anish Amin, MD, PhD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Elizaveta Kon Humanitas University Hospital

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03182374     History of Changes
Other Study ID Numbers: APSS-66-00
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Hyaluronic Acid
Hylan
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents