nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

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

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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