PRP in ACLR to Prevent PTOA

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.

PROCEDURE

placebo saline injection

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

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.