Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
NCT ID: NCT03856021
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2018-10-18
2020-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Microfracture
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.
Microfracture with Bone Marrow Aspirate Concentrate
Microfracture with Bone Marrow Aspirate Concentrate
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
Interventions
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Microfracture with Bone Marrow Aspirate Concentrate
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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RI2019Shakked
Identifier Type: -
Identifier Source: org_study_id
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