Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft

Overview

About this study

The purpose of this study would be to achieve this data analysis on both the “solid” cancellous bone grafts and the “liquid” bone marrow aspirate.  The liquid sample is more straightforward to analyze because there is no solid component that has to be first digested.  Hence, why we are first starting with feasibility analysis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclsuion 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/14/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Edward Haupt, M.D.

Contact us for the latest status

Contact information:

Edward Haupt M.D.

(904) 953-2496

Haupt.Edward@mayo.edu

More information

Publications

Publications are currently not available