Comparing Outcomes of Microfracture Versus Microfracture and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Lesions of the Talus
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
Intervention: Microfracture (Procedure)
Microfracture with Bone Marrow Aspirate Concentrate
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
