PRP in ACLR to Prevent PTOA

February 11, 2026 updated by: Hospital for Special Surgery, New York

Platelet Rich Plasma (PRP) Treatment of the Anterior Cruciate Ligament Injured Knee to Decrease the Risk of Post-traumatic Osteoarthritis (PTOA): a Randomized Double-blind Controlled Trial

The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior cruciate ligament (ACL) injury is one of the most common clinical problems among active individuals, with over 250,000 ACL reconstructions (ACLR) per year in the United States. Surgical reconstruction of the ACL is typically required in individuals who wish to return to an active lifestyle due to the presence of knee instability. The results of ACLR are predictably good as far as the ability to re-establish knee stability and to allow return to cutting and pivoting activities. However, there is a lack of effective interventions that can successfully delay or prevent the progressive degenerative changes that are known to occur following injury and that will ultimately lead to post-traumatic osteoarthritis (PTOA). PTOA accounts for nearly 12% of all cases of symptomatic OA, or approximately 5.6 million cases of lower extremity OA in the United States, carrying a cost of over $11.8 billion annually. As injury rates rise and PTOA becomes more prevalent, the associated socioeconomic burden is a significant concern since these injuries have a particularly high incidence in young adults. Many different factors likely contribute to the development of PTOA following ACLR, including the inflammatory response that occurs following injury, altered knee kinematics that can persist despite "successful" ACLR, and persistent deficits in strength of the muscles around the knee. It is well-accepted that the accumulation of inflammatory mediators and matrix degrading proteases that occurs following joint injury likely plays an important role in the initiation of the pathological process leading to PTOA. Work in animal models shows that synovial inflammation plays a central role in the development of PTOA, and studies in patients undergoing ACLR uncovered synovial fluid biomarkers with prognostic value and showed that treatment with anti-inflammatory agents modulated biomarkers of cartilage degeneration. Our preliminary RNA-seq in synovial biopsies from patients undergoing arthroscopic ACLR revealed time-dependent changes in the inflammatory gene expression profile of these tissues, further suggesting that preventative therapies that dampen inflammation early after injury and before surgery may contribute to prevent the onset of PTOA. Abnormalities in the infrapatellar fat pad (IFP) are also associated with higher inflammatory synovial fluid cytokine profile following ACL tear, highlighting the contribution of the IFP-synovial compartment to the inflammatory burden of the knee. In addition to the inflammatory response that occurs following injury, inflammation also occurs following surgery. This "double hit" may play an important role in the development of PTOA, suggesting that methods to ameliorate the inflammatory process following joint injury could represent an effective therapeutic strategy.

The current standard methods available to clinicians to treat joint inflammation include oral non-steroidal anti-inflammatory (NSAID) medications and corticosteroid injection. However, clinicians have begun to use "orthobiologics" more frequently due to their potential to diminish inflammatory and catabolic mediators while also promoting repair, and because its autologous and minimally manipulated nature is not subjected to pre-market regulatory clearance from the Food and Drug Administration. Platelet rich plasma (PRP) is a non-surgical therapy increasingly used as an alternative to NSAIDs. PRP contains and releases a wide array of bioactive molecules it has been used to treat bone, tendon, and ligament injuries, and has emerged as a potential treatment for knee osteoarthritis (OA). The currently available studies comparing intra-articular PRP injections to other means of non-surgical intervention for knee OA report promising results with the use of PRP. These data suggest that positive clinical results in OA patients are mainly related to the immune modulatory effects of PRP, dampening the intra-articular inflammatory responses.

However, the role of PRP in the treatment of knee OA remains inconclusive, largely due to inconsistencies and high variability in PRP preparations, and the limited information about the relevant components in PRP that impact clinical responses. Factors including age, sex, medical comorbidities, and genetic profile may affect the composition and biologic activity of PRP samples derived from different individuals. In addition to inter-individual variations, there is currently very little data to define how the composition and biologic activity of PRP relates to the clinical outcomes. Our recent pilot data suggests that, indeed, there are changes in composition and PRP bioactivity that may be associated with variable clinical outcomes in patients with established knee OA receiving intra-articular PRP injections. However, larger clinical trials are still required to better define these changes and to establish truly mechanistic and functional correlations. Thus, a large knowledge gap remains in our understanding of the biologically active components of PRP. Furthermore, the limited data available related to PRP and knee OA addresses treatment of established OA. There is no information available about the potential of PRP for prevention of the pathological cascade leading to PTOA.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute ACL injury within 6 weeks of presentation
  • Age 14-50
  • Male or female
  • Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)

Exclusion Criteria:

  • Prior ACL reconstruction
  • Prior cartilage repair procedure
  • Prior meniscus surgery within 12 months
  • Prior steroid, hyaluronic acid, or PRP injection within 6 months
  • Other ligament injury requiring repair
  • Any cartilage lesion requiring repair
  • Any cartilage lesion greater than grade 2 (partial thickness injury)
  • History of inflammatory arthritis or joint sepsis
  • Non English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Arm
The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection
Procedure: placebo saline injection
Patients randomized into the control arm will receive the placebo or saline injection
Experimental: Investigational Arm
The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection
Procedure: platelet rich plasma (PRP) injection
We aim to evaluate early catabolic and inflammatory changes in knee joints in patients receiving PRP injections following ACL injury, as these patients are at higher risk of developing PTOA. We also aim to establish correlations between markers of biologic activity of PRP and clinical outcomes (including both patient-reported outcomes and clinical functional outcomes), with emphasis on cellular and molecular inflammatory parameters modulated by PRP.
Other Names:
  • Autologous Conditioned Plasma (ACP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet count (Thousand/uL)
Time Frame: Baseline
Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.
Baseline
Platelet count (Thousand/uL)
Time Frame: during the procedure
Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.
during the procedure
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: Baseline

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
Baseline
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: during the procedure

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
during the procedure
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: 2 weeks post-op

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
2 weeks post-op
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: 6 weeks post-op

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
6 weeks post-op
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: 6 months post-op

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
6 months post-op
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: 12 months post-op

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
12 months post-op
Knee Injury and Osteoarthritis Outcome (KOOS-JR)
Time Frame: 24 months post-op

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities.

There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme
24 months post-op
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
Baseline
Numeric Pain Rating Scale (NPRS)
Time Frame: during the procedure

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
during the procedure
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks post-op

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
6 weeks post-op
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 months post-op

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
6 months post-op
Numeric Pain Rating Scale (NPRS)
Time Frame: 12 months post-op

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
12 months post-op
Numeric Pain Rating Scale (NPRS)
Time Frame: 24 months post-op

This survey asks about the patient's pain levels.

Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
24 months post-op
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: Baseline

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
Baseline
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: during the procedure

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
during the procedure
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: 2 weeks post-op

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
2 weeks post-op
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: 6 weeks post-op

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
6 weeks post-op
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: 6 months post-op

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
6 months post-op
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: 12 months post-op

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
12 months post-op
Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Time Frame: 24 months post-op

This survey asks about the patient's overall health and quality of life.

Patient will be reporting on a Likert Scale formatted in the following manner for questions 1-6:

5 = "Excellent", 4 = "Very good", 3 = "Good", 2 = "Fair", 1 = "Poor"

Patient will be reporting on a Likert Scale formatted in the following manner for question 7:

5 = "Completely", 4 = "Mostly", 3 = "Moderately", 2 = "A little", 1 = "Not at all"

Patient will be reporting on a Likert Scale formatted in the following manner for question 8:

1= "Never", 2 = "Rarely", 3 = "Sometimes", 4 = "Often", 5 = "Always"

Patient will be reporting on a Likert Scale formatted in the following manner for question 9:

1= "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe", 5 = "Very Severe"

For question 10: Patient will be reporting a score on a scale from 0 to 10, with 0 being "No Pain" and 10 being "Worst Pain Imaginable"
24 months post-op
Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
Baseline
Single Assessment Numeric Evaluation (SANE)
Time Frame: during the procedure

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
during the procedure
Single Assessment Numeric Evaluation (SANE)
Time Frame: 2 weeks post-op

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
2 weeks post-op
Single Assessment Numeric Evaluation (SANE)
Time Frame: 6 weeks post-op

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
6 weeks post-op
Single Assessment Numeric Evaluation (SANE)
Time Frame: 6 months post-op

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
6 months post-op
Single Assessment Numeric Evaluation (SANE)
Time Frame: 12 months post-op

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
12 months post-op
Single Assessment Numeric Evaluation (SANE)
Time Frame: 24 months post-op

This survey asks how the patient feels about their knee.

Patient will be reporting a percentage from 0% to 100%, with 100% being normal.
24 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee stability
Time Frame: 6 months post-surgery
Using the KT1000 arthrometer
6 months post-surgery
Knee stability
Time Frame: 12 months post-surgery
Using the KT1000 arthrometer
12 months post-surgery
Knee stability
Time Frame: 24 months post-surgery
Using the KT1000 arthrometer
24 months post-surgery
Knee strength
Time Frame: 6 months post-surgery
Using the Cybex test
6 months post-surgery
Knee strength
Time Frame: 12 months post-surgery
Using the Cybex test
12 months post-surgery
Knee strength
Time Frame: 24 months post-surgery
Using the Cybex test
24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthopedic Research and Education Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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