Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Unknown status

CT.gov ID

NCT03856021

Collaborator

(none)

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteochondral Lesion of Talus	Procedure: Microfracture with Bone Marrow Aspirate Concentrate Procedure: Microfracture	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 18, 2018

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

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

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

Primary Outcome Measures

Foot and Ankle Ability Measure (FAAM) [3 years following surgery]
validated patient-reported outcome measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT03856021

Other Study ID Numbers:

RI2019Shakked

First Posted:

Feb 27, 2019

Last Update Posted:

Feb 27, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Fractures, Stress

Study Results

No Results Posted as of Feb 27, 2019