P150 - A Two-Phase RCT Comparing Autologous Protein Solution with Hyaluronic Acid Intra Articular Injections in Patients with Knee OA (PROGRESS V)
Abstract
Purpose
The purpose of this study is to compare the safety and effectiveness of a single injection of nSTRIDE® APS and Synvisc-One® Hyaluronic Acid for unilateral knee osteoarthritis(NCT03182374).
Methods and Materials
Subjects with knee OA Kellgren-Lawrence 2-4(n=252) were randomized 1:1 to receive a single injection of APS or HA. Endpoints included WOMAC pain, function, stiffness, and quality of life as well as safety and change in X-ray. After 12 months, subjects were allowed a blinded second injection choice(no injection, same injection, or crossover). This analysis follows subjects for 24 months.
Results
Nine APS subjects and 16 HA subjects exited early (prior to 12-months) due to issues related to knee OA. Both groups had a significant improvement in pain from baseline with no significant difference between groups(APS:41.1 ± 34.6%;HA:40.4 ± 33.5%). Both groups had similar improvements in function, stiffness, NRS pain, EQ-5D, and responder rates. Use of restricted medication for knee OA was 8.8% in the APS group and 12.2% in the HA group at their 12-month visit. There was no difference in overall adverse event reporting between groups. At the 24-month time point, subjects that chose no second injection maintained similar pain reduction as their 12-month time point(change 0.4 for APS and -0.7 for HA). APS subjects requesting a second “same” injection had a statically significant improvement in pain at 24 months(change -1.0;p=0.03) while the HA subjects receiving the “same” second injection did not significantly improve(change -1.1;p=0.09). Subjects receiving cross over treatment did not show significant improvement from 12-month pain scores(change -1.5 for APS and -0.2 for HA). Of the original 41 subjects selecting crossover treatment, 16 rated no preference between injections while 18 preferred APS and 7 preferred HA(p=0.0417).
Conclusion
Both APS and HA improved knee OA symptoms at 12-months post injection. Subjects receiving a second APS injection statistically improved from 12 to 24 months.
