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

NCT05765266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-18

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Arthrex, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2025-07-15
Completion
2026-02-09
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765266 on ClinicalTrials.gov