nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Zimmer Biomet252 enrolled

Overview

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 50 months; 48 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

252

Conditions

Osteoarthritis, Knee

Interventions

nSTRIDE APSDEVICE

Intra-articular injection

Synvisc-OneDEVICE

Intra-articular injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

AZ Monica

Antwerp, Belgium

The Parker Institute, Frederiksberg Hospital

Copenhagen, Denmark

Praxiskliniek für Unfallchirurgie und Orthopädie

Eisenach, Germany

Outcomes

Primary Outcomes

Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will only analyze the WOMAC pain score.

Time frame: 12 months

Secondary Outcomes

Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

In a Numerical Rating Scale (NRS) pain scale, patients are asked to circle (in an horizontal bar or line) the number between 0 and 10 that fits best to their average pain intensity. 0 = No pain at all; 5 = Moderate pain; 10 = Worst possible pain

Time frame: 12 months

Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One)

The Outcome Measures in Rheumatology workgroup (OMERACT), together with the Osteoarthritis Research Society International (OARSI) developed the OMERACT-OARSI responder criteria. These criteria are used to determine if a patient with osteoarthritis (OA) 'responds' to therapy, meaning experiences a clinically relevant effect of therapy. It includes three symptomatic domains (pain, function, and patient's global assessment). To the question: High improvement in pain or in function (≥50%) and absolute change ≥20%, a positive answer is understood as "Response". A negative answer leads to an additional analysis, which seeks improvement in at least 2 of the 3 following: 1. pain ≥20% and absolute change ≥10; 2. function ≥20% and absolute change ≥10; 3. patient's global assessment ≥20% and absolute change ≥10. A positive answer here is understood as "Response". A negative answer is a "No response"

Data from ClinicalTrials.gov

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Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

Time frame: 12 months