NCT07434505 Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
| NCT ID | NCT07434505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Bone Graft |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-11-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Edward T. Haupt, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07434505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Bone Graft. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434505 currently recruiting?
Yes, NCT07434505 is actively recruiting participants. Contact the research team at Haupt.Edward@mayo.edu for enrollment information.
Where is the NCT07434505 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07434505 clinical trial?
NCT07434505 is sponsored by Mayo Clinic. The principal investigator is Edward T. Haupt, MD at Mayo Clinic. The trial plans to enroll 12 participants.