10.3.10 - A RCT of a Single, Intra-Articular Injection of Autologous Protein Solution(APS) in Patients With Knee Osteoarthritis (PROGRESS IV)
- K. Zaslav (New York, US)
- K. Zaslav (New York, US)
- F. Azar (Memphis, US)
- S. Martinez (Memphis, US)
- M. Chmell (Rockford, US)
- N. Skrepnik (Tucson, US)
- N. Segal (Kansas City, US)
- B. Grawe (Cincinnati, US)
- T. Shybut (Houston, US)
- T. Seyler (Durham, US)
- J. Woodell-May (Warsaw, US)
Abstract
Purpose
The purpose of this study is to determine the safety and effectiveness of a single injection of nSTRIDE® APS for unilateral knee osteoarthritis (NCT02905240).
Methods and Materials
This study was conducted as an Investigational Device Exemption (IDE-17069) with the FDA. Subjects with knee OA Kellgren-Lawrence 2-4 (n=332) were randomized to receive a single intra-articular injection of APS or saline under ultrasound guidance. The primary endpoint was the change in WOMAC pain from baseline to 12-months post-injection. Secondary endpoints included functional status, knee stiffness, and quality of life. Injection safety and anatomical changes were evaluated by MRI and radiographs 12 months post-injection.
Results
APS treatment showed a significant improvement in WOMAC Pain compared to baseline (51.8±36.2% improvement [95% CI 46.0, 57.7]) 12 months after a single injection, however, no significant difference in treatment effect between APS and saline was observed. No statistical differences in adverse event reporting between groups occurred. There was significant improvement at 12 months from baseline in function, stiffness, VAS pain, and EQ-5D for both groups. No major changes in joint morphology were shown for either group, as assessed by x-ray and MRI. By 12-months post-injection, saline subjects took more rescue medication, restricted medication, and exited due to knee pain at almost twice the rate of APS subjects. A novel post hoc pain responder criteria was created that accounted for medication usage and study exit rate, which demonstrated a statistically significant difference in responder rates(p=0.0239)(Figure 1).
Conclusion
Treatment with a single, intra-articular injection of APS in subjects with knee osteoarthritis can be considered safe, and was found to reduce pain and improve function up to 12 months when compared to baseline. A novel responder criterion incorporating medication usage was developed that could be used in future studies as a method to help mitigate the high placebo response typically observed in knee OA studies.