NCT07434505招募中不适用
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Characterization of Cells Present
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •Undergoing chemotherapy radiation,
- •Bone marrow transplant
- •Infection at the donor sites
- •Organ transplant on antirejection meds
- •Usage of anti-rheumatologic drugs
- •Chronic steroid usage
- •Myelodysplastic Syndromes
- •Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.
研究组 & 干预措施
Autograft Bone Harvest
Experimental
Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.
干预措施: Avitus Bone Harvester (Device)
结局指标
主要结局
Characterization of Cells Present
时间窗: Until the end of the study (approximately 18 months)
characterize what present cells can do
次要结局
- Cellular Component(Until the end of the study (approximately 18 months))
- Bone Growth Capacity(Until the end of study (approximately 18 months))
研究者
Edward T. Haupt
Principal Investigator
Mayo Clinic
研究点 (1)
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