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Platelet Rich Plasma

Experimental Group for Anterior Cruciate Ligament Rupture

Phase 2
Recruiting
Led By Adam W Anz, MD
Research Sponsored by Andrews Research & Education Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury)
Awards & highlights

Study Summary

This trial is testing whether or not a joint aspiration and platelet rich plasma injection (an early intervention) will help reduce the amount of damage caused by an anterior cruciate ligament injury, specifically by reducing the volume of inflammatory and chondrodegenerative biomarkers.

Eligible Conditions
  • Anterior Cruciate Ligament Tear
  • Anterior Cruciate Ligament Rupture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury)
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial visit (within 10 days of injury), second visit (5-12 days after the initial visit), and at the time of surgery (within 4 weeks of injury) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Receptors, Interleukin-1
Secondary outcome measures
Change in International Knee Documentation Committee Score
Change in Knee Injury and Osteoarthritis Outcome Score

Side effects data

From 2021 Phase 2 trial • 60 Patients • NCT04456153
17%
hypoxic respiratory failure
5%
Transaminitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atovaquone
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Group II: Control GroupActive Control1 Intervention
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental Group
2020
Completed Phase 4
~165280

Find a Location

Who is running the clinical trial?

Andrews Research & Education FoundationLead Sponsor
18 Previous Clinical Trials
839 Total Patients Enrolled
Adam W Anz, MDPrincipal InvestigatorAndrews Institute for Orthopaedics & Sports Medicine
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

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

To what degree are individuals at risk if they participate in the Experimental Group?

"Our team has inferred an estimation of 2 for the safety level of Experimental Group due to no available evidence for efficacy, and limited data confirming its security."

Answered by AI

Am I eligible to join this clinical experiment?

"This medical investigation is in search of 40 individuals aged 14 to 40 with a ruptured anterior cruciate ligament. Additionally, there must be no posterior cruciate ligament damage greater than grade 1 and no prior traumatic injury on the same knee."

Answered by AI

Is the eligibility criterion for this research restricted to those aged 20 and above?

"According to the research criteria, this trial is limited to individuals aged between 14 and 40. For patients under 18 or over 65 years old, there are 58 and 71 registered trials respectively."

Answered by AI

What is the estimated size of this research's participant pool?

"Yes, the records found on clinicaltrials.gov highlight that this investigation is open for recruitment. Initially revealed to the public in September 12th 2019, it was most recently revised August 4th 2022 and needs 40 participants from a single medical site."

Answered by AI

Has recruitment for this trial been initiated?

"According to the material hosted on clinicaltrials.gov, this trial is currently in search of new participants. This research program was first advertised on September 12th 2019 with its latest update being published on August 4th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
2019. "Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04088227.
~7 spots leftby Apr 2025
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