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

NCT07434505 | Recruiting FDA Device

• 1 other identifier: 24-007124
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Graft

Outcome Measures

Primary Outcomes (1)

• Characterization of Cells Present

  characterize what present cells can do

  Until the end of the study (approximately 18 months)

Secondary Outcomes (2)

• Cellular Component

  Until the end of the study (approximately 18 months)

• Bone Growth Capacity

  Until the end of study (approximately 18 months)

Study Arms (1)

Autograft Bone Harvest

EXPERIMENTAL

Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.

Device: Avitus Bone Harvester

Interventions

Avitus Bone Harvester DEVICE

Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.

Autograft Bone Harvest

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must speak English or have access to sufficient translator.

You may not qualify if:

• Patient is 70 yrs 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 to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
• Patient has any condition, which in the judgement of the Investigator, may chemically skew bone marrow. This may include but is not limited to the following:
• Cancer
• Undergoing chemotherapy radiation,
• Bone marrow transplant
• Infection at the donor sites
• Organ transplant on antirejection meds
• Usage of anti-rheumatologic drugs
• Chronic steroid usage
• Anemia

Sponsors & Collaborators

• Mayo Clinic: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Study Officials

• Edward T. Haupt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward T Haupt, M.D.

CONTACT

904-953-2496; Haupt.Edward@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 25, 2026
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)