Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
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|ClinicalTrials.gov Identifier: NCT03856021|
Recruitment Status : Unknown
Verified February 2019 by Rothman Institute Orthopaedics.
Recruitment status was: Enrolling by invitation
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
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 . 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.
|Condition or disease||Intervention/treatment||Phase|
|Osteochondral Lesion of Talus||Procedure: Microfracture with Bone Marrow Aspirate Concentrate Procedure: Microfracture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Outcomes of Microfracture Versus Microfracture and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Lesions of the Talus|
|Actual Study Start Date :||October 18, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
|Active Comparator: Microfracture||
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.
|Active Comparator: Microfracture with Bone Marrow Aspirate Concentrate||
Procedure: Microfracture with Bone Marrow Aspirate Concentrate
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
- Foot and Ankle Ability Measure (FAAM) [ Time Frame: 3 years following surgery ]validated patient-reported outcome measure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856021
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|