Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Autograft Bone Harvest 		Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.
  • Device: Avitus Bone Harvester
    Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.

Recruiting Locations

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
Contact:
Lauren M. Evans
904-953-5416

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Edward T Haupt, M.D.
904-953-2496
Haupt.Edward@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.