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Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus

NCT03856021 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-02-27

No results posted yet for this study

Summary

Osteochondral lesions of the talus are thought to be due in large part to traumatic events or repetitive microtrauma that causes damage to both the articular cartilage and the subchondral bone. There are several treatment modalities for osteochondral lesions of the talus but there is no consensus as to which is the superior method for repair.

Treatment modalities are aimed at regenerating articular cartilage. Microfracture is a widely accepted and utilized treatment for osteochondral lesions. This procedure results in pluripotent bone marrow stem cells filling the defect and ultimately differentiating into fibrocartilage-producing cells \[1\]. This technique has shown good results in both short- and medium-term follow-up for smaller lesions. Bone marrow aspirate contains mesenchymal stem cells and growth factors with cartilage regeneration potential. Bone marrow aspirate concentrate (BMAC) is a treatment modality that has shown to have to potential to produce hyaline cartilage. This study aims to analyze the effect of adding BMAC to the standard microfracture procedure in terms of clinical and radiographic outcomes in comparison to patients who only underwent microfracture treatment.

Conditions

  • Osteochondral Lesion of Talus

Interventions

PROCEDURE

Microfracture with Bone Marrow Aspirate Concentrate

Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest

PROCEDURE

Microfracture

All surgeons will use a 2 mm microfracture pick to perform the microfracture procedure. Using the 2 mm pick, surgeons will make 5 holes per 10 cm2.

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2020-10-31
Completion
2020-10-31

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 NCT03856021 on ClinicalTrials.gov