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Clinical Trials/NCT03856021
NCT03856021UnknownNot Applicable

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

Rothman Institute Orthopaedics2 sites in 1 country70 target enrollmentStarted: October 18, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Locations
2
Primary Endpoint
Foot and Ankle Ability Measure (FAAM)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Microfracture

Active Comparator

Intervention: Microfracture (Procedure)

Microfracture with Bone Marrow Aspirate Concentrate

Active Comparator

Intervention: Microfracture with Bone Marrow Aspirate Concentrate (Procedure)

Outcomes

Primary Outcomes

Foot and Ankle Ability Measure (FAAM)

Time Frame: 3 years following surgery

validated patient-reported outcome measure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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