Health TrialsbyHealthPanel

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

ConditionBone Graft
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Avitus Bone Harvester

    Device

    Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Autograft Bone HarvestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Characterization of Cells Present

characterize what present cells can do

Time frame
Until the end of the study (approximately 18 months)

Secondary outcomes

1

Cellular Component

Analysis of cellular components through counting, flow cytometry, and filtration of each sample type.

Time frame
Until the end of the study (approximately 18 months)
2

Bone Growth Capacity

Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components.

Time frame
Until the end of study (approximately 18 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Zimmer Biomet

Collaborator

Source ClinicalTrials.gov
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