N/A
Completed N=252
nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03182374 ↗
Enrolled (actual)
252
Serious AEs
6.8%
Results posted
Sep 2024
Primary outcomePrimary: 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) — 11.5; 11.9; 6.7; 7.2 score on a scale — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
11.5; 11.9; 6.7; 7.2 | <0.0001 sig |
| SECONDARY Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One) |
5.8; 6.2; 4.0; 4.4 | <0.0001 sig |
| SECONDARY Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One) |
60; 61; 42; 37 | 0.6655 |
| SECONDARY 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) |
35.4; 39.5; 20.5; 23.0 | <0.0001 sig |
| SECONDARY Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score |
68.7; 68.0; 73.4; 71.7 | <0.05 sig |
| SECONDARY Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score |
0.6; 0.6; 0.7; 0.7 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03182374). 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.