nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: nSTRIDE APS; Device: Synvisc-One

• Study Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • AZ Monica
• Denmark
  • Copenhagen, Denmark
    • The Parker Institute, Frederiksberg Hospital
• Germany
  • Eisenach, Germany
    • Praxiskliniek für Unfallchirurgie und Orthopädie
  • Straubing, Germany
    • KniePraxis
• Italy
  • Bologna, Italy
    • Rizzoli Orthopedic Institute
  • Milano, Italy
    • The Istituto Clinico Humanitas
• Netherlands
  • Maastricht, Netherlands
    • Maastricht UMC+
• Norway
  • Oslo, Norway
    • Oslo University Hospital - Olympiatoppen
• Spain
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
• Switzerland
  • Lugano, Switzerland
    • Ospedale Regionale di Lugano
• Turkey
  • Ankara, Turkey
    • Yildirim Beyazit University, School of Medicine
• United Kingdom
  • Cheltenham, United Kingdom
    • Gloucestershire Hospitals NHS Foundation Trust
  • Edinburgh, United Kingdom
    • Royal Infirmary of Edinburgh - NHS Lothian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain scale	Change in pain as measured by NRS pain scale	12 months
OMERACT-OARSI	Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria	12 months
WOMAC LK 3.1	Change in WOMAC LK 3.1 function, stiffness subscale and overall scores	12 months
EQ-5D	Change in quality of life	12 months
Adverse Events (AEs)	Occurrence of AEs	12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Elizaveta Kon, Humanitas University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Intra-articular Injection; Autologous Protein Solution (APS)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Protective Agents; Viscosupplements; Hylan
• Other Study ID Numbers: APSS-66-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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