Bone GraftNCT07434505
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
A study testing Avitus Bone Harvester in people with Bone Graft, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Graft
- What is being tested?
- Avitus Bone Harvester
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Lauren M. Evans, 904-953-5416
Edward T. Haupt, MD
About this study
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
- Being tested
- Avitus Bone Harvester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avitus Bone HarvesterDevice
Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.
| Study group | Role | What they receive |
|---|---|---|
| Autograft Bone Harvest | Experimental | Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed. Receives: Device: Avitus Bone Harvester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Cells Present
characterize what present cells can do
Measured: Until the end of the study (approximately 18 months)
Secondary outcomes (2)
Cellular Component
Analysis of cellular components through counting, flow cytometry, and filtration of each sample type.
Measured: 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.
Measured: Until the end of study (approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start6 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GraftStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Edward T. Haupt, Mayo Clinic
- Investigators
- Edward T. Haupt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434505
- Sponsor's protocol ID
- 24-007124
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
- ClinicalTrials.gov ID
- NCT07434505
- Acronym / sponsor ID
- 24-007124
- Conditions
- Bone Graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autograft Bone Harvest | Experimental | Device: Avitus Bone HarvesterPatients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avitus Bone HarvesterPatients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester. | Device | Autograft Bone Harvest |
Primary outcome
Characterization of Cells Present
Time frame: Until the end of the study (approximately 18 months)
characterize what present cells can do
2 secondary outcomes
Cellular Component
Time frame: Until the end of the study (approximately 18 months)
Bone Growth Capacity
Time frame: Until the end of study (approximately 18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward T. Haupt, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avitus Bone Harvester in people with Bone Graft, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward T Haupt, M.D. (904-953-2496, Haupt.Edward@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Cells Present (time frame: Until the end of the study (approximately 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.