Bone Graft
Conditions
Brief summary
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.
Interventions
DEVICEAvitus Bone Harvester
Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.
Sponsors
Mayo Clinic
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of Cells Present | Until the end of the study (approximately 18 months) | characterize what present cells can do |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Component | Until the end of the study (approximately 18 months) | Analysis of cellular components through counting, flow cytometry, and filtration of each sample type. |
| Bone Growth Capacity | Until the end of study (approximately 18 months) | Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components. |
Countries
United States
Contacts
CONTACTEdward T Haupt, M.D.
PRINCIPAL_INVESTIGATOREdward T. Haupt, MD
Mayo Clinic
Outcome results
None listed