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PRP Injections for ACL Injury
Phase 4
Recruiting
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 14-50
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-op
Awards & highlights
Study Summary
This trial is testing whether an injection of platelet-rich plasma can help reduce inflammation and improve function in patients with an acute ACL injury.
Who is the study for?
This trial is for individuals aged 14-50 who have recently suffered an acute ACL injury, with or without a meniscus injury treatable by surgery. It's not suitable for those with severe cartilage damage, prior knee surgeries, injections within the last 6 months, inflammatory arthritis, joint infections, or non-English speakers.Check my eligibility
What is being tested?
The study is testing if injecting platelet-rich plasma (PRP) into the injured knee can reduce inflammation and improve joint function after an ACL injury. Participants will be randomly given either PRP or a placebo saline injection to compare outcomes.See study design
What are the potential side effects?
Potential side effects of PRP injections may include pain at the injection site, infection risk increase due to needle use, tissue damage around the injected area and allergic reactions although generally considered low-risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 14 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Numeric Pain Rating Scale (NPRS)
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
+2 moreSecondary outcome measures
Knee stability
Knee strength
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational ArmExperimental Treatment1 Intervention
The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection
Group II: Control ArmPlacebo Group1 Intervention
The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection
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Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
245 Previous Clinical Trials
59,454 Total Patients Enrolled
3 Trials studying Anterior Cruciate Ligament Injury
136 Patients Enrolled for Anterior Cruciate Ligament Injury
Orthopedic Research and Education FoundationOTHER
19 Previous Clinical Trials
11,344 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a meniscus injury that can be treated with surgery.I have had a previous cartilage repair surgery.I am either male or female.I have had inflammatory arthritis or an infection in my joint.I need surgery for another ligament injury.I injured my ACL less than 6 weeks ago.I had meniscus surgery within the last year.I need surgery to fix damaged cartilage.I have not had steroid, hyaluronic acid, or PRP injections in the last 6 months.I am between 14 and 50 years old.My cartilage injury is more severe than a partial thickness tear.I have had ACL reconstruction surgery before.I have a meniscus injury that can be fixed with surgery.I am between 14 and 50 years old.I am either male or female.I injured my ACL less than 6 weeks ago.I injured my ACL less than 6 weeks ago.I have a meniscus injury that can be treated with surgery.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Investigational Arm
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anterior Cruciate Ligament Injury Patient Testimony for trial: Trial Name: NCT05412381 — Phase 4
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