NCT03182374

nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	nSTRIDE APS	Intra-articular injection
DEVICE	Synvisc-One	Intra-articular injection

Timeline

• Start date: 2017-07-14
• Primary completion: 2019-09-30
• Completion: 2023-01-30
• First posted: 2017-06-09
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

14 sites across 10 countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Spain, Switzerland, Turkey (Türkiye), United Kingdom