- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856021
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot and Ankle Ability Measure (FAAM)
Time Frame: 3 years following surgery
|
validated patient-reported outcome measure
|
3 years following surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RI2019Shakked
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteochondral Lesion of Talus
-
Assiut UniversityNot yet recruitingOsteochondral Lesion of Talus
-
Samsung Medical CenterUnknownOsteochondral Lesion of TalusKorea, Republic of
-
Hyundai Bioland Co., Ltd.Medipost Co Ltd.CompletedChondral or Osteochondral Lesion of TalusKorea, Republic of
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Not yet recruiting
-
Barmherzige Brüder EisenstadtUnknownDegenerative Lesion of Articular Cartilage of Knee | Osteochondral Lesion of Talus
-
Marmara UniversityCompletedOsteochondral Lesion of TalusTurkey
-
Southwest Hospital, ChinaUnknownOsteochondral Lesion of TalusChina
-
Geistlich Pharma AGWithdrawnChondral Defect | Osteochondral Lesion of Talus | MicrofractureUnited Kingdom
-
Peking University Third HospitalCompletedOsteochondral Lesions of the Talus
-
Peking University Third HospitalRecruitingPlatelet Rich Plasma | Osteochondral Lesion of Talus | MicrofracturesChina
Clinical Trials on Microfracture
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Zealand University HospitalSuspended
-
The Catholic University of KoreaUnknown
-
Bergen Orthopedic Study GroupCompleted
-
Histogenics CorporationTerminatedArticular Cartilage Defects in the Knee JointUnited States, Canada
-
Sewon Cellontech Co., Ltd.UnknownOsteoarthritis | Defect of Articular Cartilage | Traumatic ArthritisKorea, Republic of
-
L&C BioActive, not recruitingOsteoarthritis, KneeKorea, Republic of
-
Nova Scotia Health AuthorityWithdrawnDisorder of Hip Region
-
HistogenUnited States Department of DefenseTerminatedCartilage Damage | Articular Cartilage Disorder of Knee | MicrofracturesUnited States
-
L&C BioActive, not recruitingOsteoarthritis, KneeKorea, Republic of
-
Affiliated Hospital of Nantong UniversityRecruitingRotator Cuff Tears | Micro FractureChina