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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
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteochondral Lesion of Talus Procedure: Microfracture with Bone Marrow Aspirate Concentrate Procedure: Microfracture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Microfracture Procedure: 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


Outcome Measures
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Primary Outcome Measures :
  1. Foot and Ankle Ability Measure (FAAM) [ Time Frame: 3 years following surgery ]
    validated patient-reported outcome measure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03856021    
Other Study ID Numbers: RI2019Shakked
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries