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Platelet-Rich Plasma System

ACP Max™ for Osteoarthritis

N/A

Waitlist Available

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 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Medication Usage

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arthrex, Inc.Lead Sponsor

44 Previous Clinical Trials

29,837 Total Patients Enrolled

3 Trials studying Osteoarthritis

503 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to participate in this clinical trial?

"In order to be eligible for participation in this investigation, candidates must have a diagnosis of osteoarthritis and fall within the age range of 18 to 75 years. The research study aims to enroll approximately 45 individuals."

Answered by AI

Are there any available openings for patients to participate in this study?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. The initial posting was made on February 29th, 2024 and it was last updated on January 4th, 2024. However, there are presently 649 other ongoing studies actively recruiting patients at this time."

Answered by AI

Is the age criterion for participation in this medical study inclusive of individuals who are 65 years or older?

"To be eligible for this clinical trial, individuals must fall within the age range of 18 to 75 years. It is worth noting that there are a total of 34 trials available specifically for patients under the age of 18 and 606 trials catering to participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05765266.

All > Knee Osteoarthritis