Actively Recruiting
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
Led by Mayo Clinic · Updated on 2026-02-25
12
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
Z
Zimmer Biomet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 BMA (e.g. no history of bilateral total knee arthroplasties or previous iliac wing trauma bilaterally).
- Patient is skeletally mature and presents with no concern for osteopenia or 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.
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, which in the judgement of the Investigator, places the patient at undue risk or interferes with the study.
- Patient has mental or neurological disorder that will not allow for proper informed consent.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation entails, known alcohol or drug abuser, and/or anticipated to be non-compliant).
- Patient has any condition which may chemically skew bone marrow, including cancer, undergoing chemotherapy or radiation, bone marrow transplant, infection at donor sites, organ transplant on antirejection medications, use of anti-rheumatologic drugs, chronic steroid usage, anemia, or myelodysplastic syndromes.
- Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
E
Edward T Haupt, M.D.
CONTACT
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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