PRP in ACLR to Prevent PTOA

NCT05412381 | Recruiting Phase 3 FDA Device

• 1 other identifier: 2021-0984
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injuries; Post-traumatic Osteoarthritis; PRP

Keywords

platelet-rich plasma; regenerative medicine; anterior cruciate ligament reconstruction; post-traumatic osteoarthritis

Outcome Measures

Primary Outcomes (29)

• Platelet count (Thousand/uL)

  Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.

  Baseline

• Platelet count (Thousand/uL)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (6)

• Knee stability

  6 months post-surgery

• Knee stability

  12 months post-surgery

• Knee stability

  24 months post-surgery

• Knee strength

  6 months post-surgery

• Knee strength

  12 months post-surgery

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection

Procedure: placebo saline injection

Investigational Arm

EXPERIMENTAL

The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection

Procedure: platelet rich plasma (PRP) injection

Interventions

platelet rich plasma (PRP) injection PROCEDURE

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.

Also known as: Autologous Conditioned Plasma (ACP)

Investigational Arm

placebo saline injection PROCEDURE

Patients randomized into the control arm will receive the placebo or saline injection

Control Arm

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Injections

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jessica Andres-Bergos, PhD

CONTACT

(917) 260-4694; andresbergosj@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRP is considered a biologic. We designed a double-blinded randomized controlled clinical trial with two arms: 1. Control Arm (pre-op placebo injection, ACLR surgery + placebo injection) 2. Investigational Arm (pre-op PRP injection, ACLR surgery + PRP injection).

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: June 9, 2022
• Study Start: June 27, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (1)