Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
Primary Purpose
Osteochondral Lesion of Talus
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microfracture with Bone Marrow Aspirate Concentrate
Microfracture
Sponsored by
About this trial
This is an interventional treatment trial for Osteochondral Lesion of Talus
Eligibility 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
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Microfracture
Microfracture with Bone Marrow Aspirate Concentrate
Arm Description
Outcomes
Primary Outcome Measures
Foot and Ankle Ability Measure (FAAM)
validated patient-reported outcome measure
Secondary Outcome Measures
Full Information
NCT ID
NCT03856021
First Posted
February 25, 2019
Last Updated
February 25, 2019
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03856021
Brief Title
Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
Official Title
Comparing Outcomes of Microfracture Versus Microfracture and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Lesions of the Talus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondral Lesion of Talus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microfracture
Arm Type
Active Comparator
Arm Title
Microfracture with Bone Marrow Aspirate Concentrate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Microfracture with Bone Marrow Aspirate Concentrate
Intervention Description
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM)
Description
validated patient-reported outcome measure
Time Frame
3 years following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
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