Iliac crest marrow versus proximal tibia Avitus bone graft for foot and ankle procedures
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
This will test whether bone graft taken from the proximal tibia with the Avitus device works as well as iliac crest bone marrow for adults needing autograft during foot or ankle fusion or nonunion surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07434505 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for ankle, hindfoot, or complex mid/forefoot fusion or treatment of nonunions who require autograft will be enrolled at Mayo Clinic Jacksonville. Each participant will have marrow or graft material obtained from the iliac crest and from the proximal tibia using the Avitus Bone Harvester so comparative samples can be collected. Samples will be compared for harvest volume and cellular/material properties, and patients will be followed for immediate procedural outcomes and donor-site morbidity. Preoperative radiographs of the knee and pelvis will confirm suitability of harvest sites.
Who should consider this trial
Good fit: Adults aged 18–69 who are skeletally mature, speak English or have a translator, and are scheduled for indicated foot or ankle fusion or nonunion surgery with an indication for both proximal tibia autograft and iliac crest bone marrow aspiration and sufficient harvest volume are ideal candidates.
Not a fit: Patients aged 70 or older, those with osteopenia/osteoporosis, prior bilateral iliac wing trauma or bilateral total knee arthroplasties, insufficient harvest volume, or who are not undergoing the specified procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, the Avitus proximal tibia harvest could provide similar graft material with less donor-site pain and fewer complications than traditional iliac crest harvest.
How similar studies have performed: Prior reports suggest proximal tibia harvest can yield comparable cell counts to iliac crest marrow in some settings, but device-specific head-to-head data for the Avitus harvester are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Edward T. Haupt, MD — Mayo Clinic
- Study coordinator: Edward T Haupt, M.D.
- Email: Haupt.Edward@mayo.edu
- Phone: 904-953-2496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.