Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft

Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft

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.

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.