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

NCT05765266 | Completed DMC FDA Device

• 1 other identifier: AIRR-0032
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months.

  6 months

• Adverse Events

  Analysis of the frequency and severity of all adverse events for the investigational group at 12 months.

  12 months

Secondary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale

  Day 10, 6 weeks, 3, 6, 9 and 12 Months

• Medication Usage

  Day 10, 6 weeks, 3, 6, 9 and 12 months

Study Arms (2)

ACP Max™

EXPERIMENTAL

Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™

Device: ACP Max™

40 mg of methylprednisolone acetate

ACTIVE COMPARATOR

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.

Device: Depo-Medrol®

Interventions

ACP Max™ DEVICE

Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™

ACP Max™

Depo-Medrol® DEVICE

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.

Also known as: methylprednisolone acetate)

40 mg of methylprednisolone acetate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject voluntarily decides to participate and signs the consent form.
• Subject is ≥ 18 to 75 years of age.
• Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications.
• Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening.
• Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities.
• Subject consents to a washout period of NSAIDs and analgesics 7 days before each study visit (except low-dose aspirin for prevention of cardiovascular disease).
• Subject has a Body Mass Index ≤ 35 kg/m2

You may not qualify if:

• Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale.
• Subject has clinically 3+ effusion of the target knee (stroke test grading system).
• Subject has significant (\> 10°) valgus or varus deformities as evidenced by standard of care x-ray.
• Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening.
• Subject did not achieve initial pain relief from prior corticosteroid injections.
• Subject has received an IA injection of HA in the target knee within 6 months prior to screening.
• Subject has received an IA injection of PRP in the target knee at any time prior to screening.
• Subject has a history of coagulopathy.
• Subject has joint pain reflected by a VAS score of \> 35 mm out of 100 mm scale in the contralateral knee at the time of screening.
• Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months.
• Subject has an inflammatory disease of either knee other than OA.
• Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome.
• Subject with a positive pregnancy test or breastfeeding.
• Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months.
• Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (3)

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where subjects and evaluators are blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: May 13, 2024
• Primary Completion: July 15, 2025
• Study Completion: February 9, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)