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

Not Applicable

• Conditions: Osteochondral Lesion of Talus
• Interventions: Procedure: Microfracture; Procedure: Microfracture with Bone Marrow Aspirate Concentrate

• Registration Number: NCT03856021
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-18
• Status Verified: 2019-02
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfracture	Microfracture	-
Microfracture with Bone Marrow Aspirate Concentrate	Microfracture with Bone Marrow Aspirate Concentrate	-

Primary Outcome Measures

Name	Time	Method
Foot and Ankle Ability Measure (FAAM)	3 years following surgery	validated patient-reported outcome measure

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States