Actively Recruiting
Comparison of Iliac Crest Marrow versus Proximal Tibia Avitus4 Bone Graft in Orthopedic Foot and Ankle Surgery
Led by Mayo Clinic · Updated on 2026-02-25
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
Z
Zimmer Biomet
Collaborating Sponsor
AI-Summary
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 study's 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.
CONDITIONS
Brief Title
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 bone marrow aspirate with no history of bilateral total knee arthroplasties or previous iliac wing trauma bilaterally
- Patient is skeletally mature and has no concern for osteopenia or osteoporosis
- Patient has sufficient volume of harvest material (minimum 10 ml cancellous bone graft plus 10 ml fluid pressed out from cancellous bone portion)
- Patient must speak English or have access to sufficient translator
You will not qualify if you...
- Patient is 70 years of age or older
- Patient is unwilling or unable to give consent or comply with study protocol
- Patient has any condition that places the patient at undue risk or interferes with the study in the judgment of the Investigator
- Patient has mental or neurological disorders preventing proper informed consent
- Patient is known to be pregnant or breastfeeding
- Patient is a vulnerable subject (prisoner, mentally incompetent, known alcohol or drug abuser, or anticipated to be non-compliant)
- Patient has conditions that may chemically skew bone marrow, including cancer, undergoing chemotherapy or radiation, bone marrow transplant, infection at donor sites, organ transplant on antirejection meds, use of anti-rheumatologic drugs, chronic steroid use, anemia, or myelodysplastic syndromes
- Patient has knee arthritis and may require knee replacement within the next 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery
Participants undergo orthopedic foot and ankle surgery that includes an autograft bone harvest using the Avitus Bone Harvester device.
1 surgery and immediate post-operative visit
Duration - Up to 18 months
Participants are monitored for bone growth capacity and cellular characteristics for up to approximately 18 months following surgery.
Periodic follow-up visits over 18 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
E
Edward T Haupt, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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