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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
Pivotal Trial
Drug Has Already Been Approved

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

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

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 more
Secondary outcome measures
Knee stability
Knee strength

Awards & Highlights

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.

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
240 Previous Clinical Trials
61,940 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

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

Frequently Asked Questions

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

Are any new participants currently being recruited for this research study?

"Per the information on clinicaltrials.gov, this medical investigation is currently seeking recruits for their trial that was first posted on June 27th 2022 and most recently updated July 14th of the same year."

Answered by AI

Is this research endeavor including individuals aged 30 or above?

"This particular trial is recruiting patients aged 14 to 50. There are 75 trials for minors and 611 studies targeting the elderly population."

Answered by AI

What is the current count of participants in this trial?

"Yes, the information made available on clinicaltrials.gov verifies that this research is currently in search of individuals. This investigation was originally posted on June 27th 2022 and modified most recently on July 14th 2022. 56 volunteers are needed to be recruited from 1 site."

Answered by AI

What are the eligibility criteria for participation in this experimental research?

"This trial is actively seeking 56 individuals aged between 14 and 50, who have sustained a recent ACL tear. Besides meeting the age criteria, participants should display an acute ligament injury within 6 weeks of their presentation; in addition to any accompanying meniscus-related damage that can be treated with either repair or removal (absence of such harm will not bar enrolment)."

Answered by AI

Has the FDA accepted platelet rich plasma (PRP) injection as a viable form of therapy?

"The safety of a platelet rich plasma (PRP) injection has been verified by the fourth stage of trials, thus it received an impressive score of 3."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Maryland
New York
How old are they?
18 - 65
65+
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To get pregnant with my own eggs.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Hospital for Special Surgery: < 24 hours
Average response time
  • < 1 Day
~19 spots leftby Dec 2024