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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2018
CompletedFirst Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFebruary 27, 2019
February 1, 2019
2 years
February 25, 2019
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Foot and Ankle Ability Measure (FAAM)
validated patient-reported outcome measure
3 years following surgery
Study Arms (2)
Microfracture
ACTIVE COMPARATORMicrofracture with Bone Marrow Aspirate Concentrate
ACTIVE COMPARATORInterventions
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
All 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unwilling to sign informed consent document
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
February 27, 2019
Study Start
October 18, 2018
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share