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Other

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
Must not have
Prior ACL reconstruction
Prior cartilage repair procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-op
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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 below
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I am between 14 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had ACL reconstruction surgery before.
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I have had a previous cartilage repair surgery.
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I need surgery for another ligament injury.
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I need surgery to fix damaged cartilage.
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My cartilage injury is more severe than a partial thickness tear.
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I have had inflammatory arthritis or an infection in my joint.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Numeric Pain Rating Scale (NPRS)
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
+2 more
Secondary study objectives
Knee stability
Knee strength

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,280 Total Patients Enrolled
3 Trials studying Anterior Cruciate Ligament Injury
136 Patients Enrolled for Anterior Cruciate Ligament Injury
Orthopedic Research and Education FoundationOTHER
20 Previous Clinical Trials
5,614 Total Patients Enrolled

Media Library

Placebo Saline Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05412381 — Phase 4
Anterior Cruciate Ligament Injury Research Study Groups: Control Arm, Investigational Arm
Anterior Cruciate Ligament Injury Clinical Trial 2023: Placebo Saline Injection Highlights & Side Effects. Trial Name: NCT05412381 — Phase 4
Placebo Saline Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412381 — Phase 4
Anterior Cruciate Ligament Injury Patient Testimony for trial: Trial Name: NCT05412381 — Phase 4
~2 spots leftby Dec 2024