The trial is taking place at:
H

Hospital Universitario Puerta de Hierro Majadahonda | Departamento de Oncologia Medica

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nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

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Zimmer Biomet

Status

Active, not recruiting

Conditions

Osteoarthritis, Knee

Treatments

Device: nSTRIDE APS
Device: Synvisc-One

Study type

Interventional

Funder types

Industry

Identifiers

NCT03182374
APSS-66-00

Details and patient eligibility

About

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.

Enrollment

246 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

246 participants in 2 patient groups

nSTRIDE APS
Active Comparator group
Description:
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.
Treatment:
Device: nSTRIDE APS
Synvisc-One
Active Comparator group
Description:
Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee
Treatment:
Device: Synvisc-One

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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