NCT05765266

ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).

Detailed description

All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ACP Max™	Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
DEVICE	Depo-Medrol®	Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml.

Timeline

• Start date: 2024-05-13
• Primary completion: 2025-07-15
• Completion: 2026-02-09
• First posted: 2023-03-13
• Last updated: 2026-02-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study