N/A
Completed N=332
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Source: ClinicalTrials.gov NCT02905240 ↗Enrolled (actual)
332
Serious AEs
4.8%
Results posted
Oct 2023
Primary outcomePrimary: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months — -5.6; -5.4 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months |
-5.6; -5.4 | — |
| SECONDARY Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months |
-25.8; -23.4 | — |
| SECONDARY Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders |
101; 92; 48; 42 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months |
-2.1; -2.2 | — |
| SECONDARY EQ-5D Change From Baseline to 12 Months |
4.62; 4.06 | — |
| SECONDARY Adverse Events |
94; 93 | — |
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
Data sourced from ClinicalTrials.gov (NCT02905240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.