Clinical Trials Directory

Trials / Unknown

UnknownNCT03856021

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

Comparing Outcomes of Microfracture Versus Microfracture and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Lesions of the Talus

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Rothman Institute Orthopaedics · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREMicrofracture with Bone Marrow Aspirate ConcentrateBone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
PROCEDUREMicrofractureAll 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.

Timeline

Start date
2018-10-18
Primary completion
2020-10-01
Completion
2020-10-01
First posted
2019-02-27
Last updated
2019-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03856021. Inclusion in this directory is not an endorsement.