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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Unknown

Conditions

Osteochondral Lesion of Talus

Treatments

Procedure: Microfracture
Procedure: Microfracture with Bone Marrow Aspirate Concentrate

Study type

Interventional

Funder types

Other

Identifiers

NCT03856021
RI2019Shakked

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Greater than 18 years of age and scheduled for surgery to treat osteochondral lesion of the talus Able and willing to sign informed consent document

Exclusion criteria

Unwilling to sign informed consent document

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Microfracture
Active Comparator group
Treatment:
Procedure: Microfracture
Microfracture with Bone Marrow Aspirate Concentrate
Active Comparator group
Treatment:
Procedure: Microfracture with Bone Marrow Aspirate Concentrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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