Recruiting

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

Sponsor:

Mayo Clinic

Code:

NCT07434505

Conditions

Bone Graft

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Avitus Bone Harvester

Study Details

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

Study ID

NCT07434505

Start date

Nov 6, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autograft Bone Harvest

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

Interventions

Avitus Bone Harvester

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

Primary outcome measure

Characterization of Cells Present [ Time Frame: Until the end of the study (approximately 18 months) ]

Central Contacts and Locations

Central contacts

Edward T Haupt, M.D.

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

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Lauren M. Evans

904-953-5416

Principal Investigator:

Edward T. Haupt, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-25.