Study Comparing Iliac Crest Marrow and Proximal Tibia Avitus Bone Graft Techniques for Patients Needing Bone Graft During Foot and Ankle Surgery

What this Trial Is About

Researchers are evaluating the Avitus Bone Harvester device and comparing its bone marrow aspirate harvesting technique to the traditional iliac crest marrow method in patients requiring bone grafts. The study aims to provide comparative data on the types and characteristics of cells collected by each method to better understand their equivalence for orthopedic foot and ankle surgeries involving autograft bone harvest. Participants in this interventional study will undergo standard orthopedic foot and ankle surgery requiring autograft bone harvest. In addition to usual care, one extra bone marrow sample will be collected using the Avitus Bone Harvester from the proximal tibia, alongside iliac crest bone marrow aspirate. The study will monitor and compare cell characteristics and bone growth capacity over approximately 18 months. During the study, patients will have preoperative knee and pelvis X-rays to confirm suitability of harvest sites. Researchers will assess the cellular components and bone growth potential of the harvested material until the studys end, about 18 months later. Participants will be monitored for safety and study compliance throughout. The total participation duration will cover the surgical procedure plus follow-up assessments over this period.

Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft