Recruiting NCT07434505
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avitus Bone Harvester.
- Who it may be relevant to
- Registry conditions: Bone Graft. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- 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.
Primary outcome measures
- Characterization of Cells Present [Time frame: Until the end of the study (approximately 18 months)]
Secondary outcome measures (2)
- Cellular Component [Time frame: Until the end of the study (approximately 18 months)]
- Bone Growth Capacity [Time frame: Until the end of study (approximately 18 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Jacksonville
Identifiers
NCT: NCT07434505 · 24-007124