Overview
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
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.
