Anterior Cruciate Ligament InjuriesPhase 3NCT05412381
PRP in ACLR to Prevent PTOA
A Phase 3 study testing platelet rich plasma (PRP) injection in people with Anterior Cruciate Ligament Injuries and Post-traumatic Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, PRP
- What is being tested?
- platelet rich plasma (PRP) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Any cartilage lesion greater than grade 2 (partial thickness injury)
- History of inflammatory arthritis or joint sepsis
- Non English speakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Jessica Andres-Bergos, PhD, 9172604694, andresbergosj@hss.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- platelet rich plasma (PRP) injection, placebo saline injection
- Keywords
- platelet-rich plasma, regenerative medicine, anterior cruciate ligament reconstruction, post-traumatic osteoarthritis
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma (PRP) injectionProcedure or surgery
Also called Autologous Conditioned Plasma (ACP)
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.
placebo saline injectionProcedure or surgery
Patients randomized into the control arm will receive the placebo or saline injection
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection Receives: Procedure: placebo saline injection |
| Investigational Arm | Experimental | The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection Receives: Procedure: platelet rich plasma (PRP) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count (Thousand/uL)
Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.
Measured: Baseline
Platelet count (Thousand/uL)
Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months post-op
Secondary outcomes (6)
Knee stability
Using the KT1000 arthrometer
Measured: 6 months post-surgery
Knee stability
Using the KT1000 arthrometer
Measured: 12 months post-surgery
Knee stability
Using the KT1000 arthrometer
Measured: 24 months post-surgery
Knee strength
Using the Cybex test
Measured: 6 months post-surgery
Knee strength
Using the Cybex test
Measured: 12 months post-surgery
Knee strength
Using the Cybex test
Measured: 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start27 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412381
- Sponsor's protocol ID
- 2021-0984
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05412381
- Acronym / sponsor ID
- 2021-0984
- Keywords
- platelet-rich plasma, regenerative medicine, anterior cruciate ligament reconstruction, post-traumatic osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Procedure: placebo saline injectionThe control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection |
| Investigational Arm | Experimental | Procedure: platelet rich plasma (PRP) injectionThe investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasma (PRP) injectionAlso: Autologous Conditioned Plasma (ACP)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. | Procedure or surgery | Investigational Arm |
| placebo saline injectionPatients randomized into the control arm will receive the placebo or saline injection | Procedure or surgery | Control Arm |
Primary outcome
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.
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.
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
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
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
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
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
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
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
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"
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"
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"
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"
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"
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"
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"
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"
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"
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"
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"
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"
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"
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Knee stability
Time frame: 6 months post-surgery
Knee stability
Time frame: 12 months post-surgery
Knee stability
Time frame: 24 months post-surgery
Knee strength
Time frame: 6 months post-surgery
Knee strength
Time frame: 12 months post-surgery
Knee strength
Time frame: 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Related informationLink provided by the sponsor.
- Related informationLink provided by the sponsor.
- Related informationLink provided by the sponsor.
- Related informationLink provided by the sponsor.
- Related informationLink provided by the sponsor.
- Related informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing platelet rich plasma (PRP) injection in people with Anterior Cruciate Ligament Injuries and Post-traumatic Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Andres-Bergos, PhD ((917) 260-4694, andresbergosj@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count (Thousand/uL) (time frame: Baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.