NCT07434505 Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
| NCT ID | NCT07434505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Bone Graft |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this research is to provide comparative data about the Avitus product and its equivalence to other Bone Marrow Aspirate (BMA) harvesting techniques.
Eligibility Criteria
Inclusion Criteria: * Patient must be 18 years of age or older. * Patient must be able and willing to sign the IRB approved informed consent. * Patient must consent to preoperative knee and pelvis radiographs to confirm no issue at harvest location. * Patient has indication for autograft bone harvest (undergoing any ankle or hindfoot fusion, complex mid and forefoot fusions requiring graft supplementation, treatment of fuse and fracture nonunions) * Patient is indicated for proximal tibia autograft harvest and iliac crest BMA (e.g. no hx bilateral TKAs or previous iliac wing trauma bilaterally). * Patient is skeletally "mature" and presents with no concern for osteopenia/osteoporosis. * Patient has sufficient volume of harvest material for study inclusion (minimum of 10 ml of cancellous bone graft plus 10 ml fluid pressed out from cancellous bone portion) * Patient must speak English or have access to sufficient translator. Exclusion Criteria: * Patient is 70 yrs of age or older. * Pat