Trials / Unknown
UnknownNCT03856021
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Rothman Institute Orthopaedics · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Microfracture with Bone Marrow Aspirate Concentrate | Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest |
| 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. |
Timeline
- Start date
- 2018-10-18
- Primary completion
- 2020-10-01
- Completion
- 2020-10-01
- First posted
- 2019-02-27
- Last updated
- 2019-02-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03856021. Inclusion in this directory is not an endorsement.