ACP Max™ for Knee Osteoarthritis
Trial Summary
Do I have to stop taking my current medications for the trial?
Participants must stop taking NSAIDs and analgesics 7 days before each study visit, except for low-dose aspirin used for heart disease prevention.
What data supports the effectiveness of the treatment ACP Max™ for knee osteoarthritis?
Research shows that autologous conditioned plasma (ACP) and platelet-rich plasma (PRP) have promising results in treating knee osteoarthritis, with some studies indicating they may be as effective as other therapies. Additionally, methylprednisolone acetate injections have been shown to benefit knee osteoarthritis symptoms.12345
Is ACP Max™ safe for treating knee osteoarthritis?
How is the treatment ACP Max™ for knee osteoarthritis different from other treatments?
What is the purpose of this trial?
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).
Eligibility Criteria
This trial is for adults aged 18 to 75 with knee osteoarthritis who've tried oral meds or anti-inflammatories for at least 6 months without relief. They need X-rays showing certain levels of joint damage and significant pain despite treatment. Participants must not be overweight (BMI ≤ 35) and agree to stop taking NSAIDs a week before visits.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single 4-6 ml intra-articular injection of either ACP Max™ or Depo-Medrol®
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ACP Max™
- Depo-Medrol®
ACP Max™ is already approved in United States for the following indications:
- Knee Osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arthrex, Inc.
Lead Sponsor