Iliac crest marrow versus proximal tibia Avitus bone graft for foot and ankle procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.