Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.

Detailed Description
-----------------
A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: nSTRIDE APS
* Device: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 21 and ≤ 80 years old at the time of screening Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis Body Mass Index ≤ 40 A qualifying WOMAC LK 3.1 pain subscale total score Has undergone at least one prior conservative osteoarthritis treatment Signed an institutional review board approved informed consent Exclusion Criteria: Presence of clinically observed active infection in the index knee Presence of symptomatic osteoarthritis in the non-study knee 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 Untreated symptomatic injury of the index knee Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee Previous cartilage repair procedure on the injured cartilage surface of the index knee Arthroplasty or open surgery of the index knee within 6 months of screening Intra-articular steroid injection in the index knee within 3 months of screening Intra-articular hyaluronic acid injection in the index knee within 6 months of screening Other intra-articular therapy in the index knee within 6 months prior to screening Orally administered systemic steroid use within 2 weeks of screening Planned/anticipated surgery of the index knee during the study period Skin breakdown at the knee where the injection is planned to take place Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study Participated in any investigational drug or device trial within 30 days prior to screening Participated in any investigational biologic trial within 60 days prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nSTRIDE APS<br>Autologous Protein Solution prepared using the nSTRIDE APS Kit | Device: nSTRIDE APS<br>* single intra-articular injection<br>* Other names: Autologous Protein Solution;|
| Other: Saline<br>Saline control | Device: Saline<br>* single intra-articular injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months | The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). | Baseline and 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months | The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right. | Baseline and 12 Months | 
| Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders | The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of ≥50% and absolute change ≥20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment). | 12 months | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months | The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness). | Baseline and 12 Months | 
| EQ-5D Change From Baseline to 12 Months | The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline and 12 Months | 
| Adverse Events | Subjects experiencing at least one AE | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
APS, Autologous Protein Solution, intra-articular injection, osteoarthritis