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NCT Number: NCT07434505

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.

Recruiting

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Edward T. Haupt, MD

PRINCIPAL_INVESTIGATOR

Lauren M. Evans

CONTACT

904-953-5416

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Characterization of Cells Present

    Time frame: Until the end of the study (approximately 18 months)

    characterize what present cells can do

Secondary outcomes

  1. Cellular Component

    Time frame: Until the end of the study (approximately 18 months)

    Analysis of cellular components through counting, flow cytometry, and filtration of each sample type.

  2. Bone Growth Capacity

    Time frame: Until the end of study (approximately 18 months)

    Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components.

Study contacts

Contact information is provided by the study sponsor or research team.

Edward T Haupt, M.D.

CONTACT

[email protected]

904-953-2496

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Zimmer Biomet

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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