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Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction

NCT04205656 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-07-16

No results posted yet for this study

Summary

This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Leukocyte-Poor Platelet Rich Plasma (LP-PRP)

Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.

BIOLOGICAL

Bone Marrow Concentrate (BMC)

Participants will have a knee injected with BMC stem cells harvested from the iliac crest

OTHER

Control group (Placebo)

Participants will undergo ACLR surgery with no injection into their knee.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Office of Naval Research (ONR)

    collaborator FED

  • Steadman Philippon Research Institute

    lead OTHER

Principal Investigators

  • Peter Millett, MD · The Steadman Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2024-07-31
Completion
2024-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205656 on ClinicalTrials.gov