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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Graft
• Intervention / Treatment: Device: Avitus Bone Harvester

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward T Haupt, M.D.; Phone Number: 904-953-2496; Email: Haupt.Edward@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Lauren M. Evans; Phone Number: 904-953-5416
      • Principal Investigator: Edward T. Haupt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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
  • Myelodysplastic Syndromes
• Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autograft Bone Harvest; Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.	Device: Avitus Bone Harvester; Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of Cells Present	characterize what present cells can do	Until the end of the study (approximately 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular Component	Analysis of cellular components through counting, flow cytometry, and filtration of each sample type.	Until the end of the study (approximately 18 months)
Bone Growth Capacity	Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components.	Until the end of study (approximately 18 months)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Edward T. Haupt, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-007124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes