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NCT04088227 · ClinicalTrials.gov registry record · Phase 2

Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears

A Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture, sponsored by Andrews Research & Education Foundation.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
1
Study location

NCT04088227 is a Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture that has completed, run by Andrews Research & Education Foundation. The registered enrollment target is 24 participants, below the 228-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04088227, a Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture, has completed, sponsored by Andrews Research & Education Foundation.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis. The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

Interventions

  • OTHER Control Group
  • DRUG Experimental Group

Study Locations (1)

Florida

  • Andrews Institute for Orthopaedics & Sports Medicine - Gulf Breeze

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2019-09-12
Est. Completion 2023-04-21
Phase Phase 2

What the Registry Record Tells You About NCT04088227

The ClinicalTrials.gov registry entry for NCT04088227 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (89% lower). The listed sponsor is Andrews Research & Education Foundation, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anterior Cruciate Ligament Tear appearing as the primary indexed condition, and to 2 interventions - of which Control Group is the first listed.

NCT04088227 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT04088227 about?

NCT04088227 is a clinical study titled "Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears". A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis fol...

What is the current status of trial NCT04088227?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2019-09-12. Estimated completion is 2023-04-21.

What conditions does trial NCT04088227 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture.

What interventions are being tested in trial NCT04088227?

The interventions under investigation include: Control Group (OTHER), Experimental Group (DRUG).

Who is sponsoring clinical trial NCT04088227?

This trial is sponsored by Andrews Research & Education Foundation, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04088227 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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