An interventional study of Microfracture with Bone Marrow Aspirate Concentrate and Microfracture in Osteochondral Lesion of Talus, sponsored by Rothman Institute Orthopaedics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Treatment
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.
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's planned enrollment of 70 is close to the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Procedure: Microfracture
Procedure: Microfracture with Bone Marrow Aspirate Concentrate
Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
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.
Foot and Ankle Ability Measure (FAAM)
validated patient-reported outcome measure
Time frame: 3 years following surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rothman Institute Orthopaedics