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Platelet-Rich Plasma System

ACP Max™ for Knee Osteoarthritis

N/A
Recruiting
Research Sponsored by Arthrex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 is ≥ 18 to 75 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will include 45 patients who will be randomly assigned to receive either a single injection of ACP Max™ or Depo-Medrol®. The purpose of this study is to compare the

Who is the study for?
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.
What is being tested?
The study tests the ACP Max™ PRP System against Depo-Medrol® injections in people with knee osteoarthritis. It's a controlled test where patients are randomly chosen to receive one of these treatments, but neither they nor the doctors know which one until after the results are collected.
What are the potential side effects?
Potential side effects may include injection site reactions like pain, swelling, and bruising. Since Depo-Medrol® is a steroid, it might also cause skin thinning or color changes at the injection site, increased blood sugar levels, and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My knee pain is severe and it's hard for me to do daily activities.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Medication Usage
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ACP Max™Experimental Treatment1 Intervention
Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
Group II: 40 mg of methylprednisolone acetateActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Arthrex, Inc.Lead Sponsor
46 Previous Clinical Trials
29,927 Total Patients Enrolled
4 Trials studying Osteoarthritis
535 Patients Enrolled for Osteoarthritis
~15 spots leftby May 2025
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