nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: nSTRIDE APS
* Device: Synvisc-One


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nSTRIDE APS<br>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<br>* Intra-articular injection<br>* Other names: Autologous Protein Solution;|
| Active Comparator: Synvisc-One<br>Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee | Device: Synvisc-One<br>* Intra-articular injection<br>* Other names: hylan G-F 20;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Protein Solution (APS), Intra-articular Injection, Osteoarthritis