Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) in Patients Undergoing Anterior Cervical Discectomy and Fusion
研究概览
地位
条件
详细说明
When conservative care fails to alleviate the pain and neurological deficits caused by degenerative disc disease in a cervical spine, the most common recourse is surgical decompression of the affected nerves and/or spinal cord. Decompression is often accomplished via an anterior approach whereby essentially the entire disc as well as any bony osteophytes and ligaments that are compressing the spinal cord and/or nerves are removed. While usually successful at decompressing affected neural structures, the decompression often results in collapse of the disc space, instability and recurrent symptomatology.
Most anterior cervical decompressions therefore are followed by insertion of a structural interbody spacer such as a bone graft from the patient's iliac crest (autograft) or a bone graft from a cadaver (allograft). The "gold standard" for aiding healing in spinal fusion surgeries is the harvesting of autograft from the patient's iliac crest and placing it in and around the segments of the spine that are intended to be fused. Autograft is considered the "gold standard" because it contains the essential elements required for successful bone grafting: osteogenesis, osteoconduction, and osteoinduction.
However, the morbidity of harvesting autograft has been well documented and includes chronic donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and prolonged surgical and hospitalization time. There are now a number of products on the market to minimize or replace the use of autograft. However, few of these products contain all three essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction) in a single, stand alone product.
Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Encinitas、California、美国、92024
- CORE Orthopaedic Medical Center
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Redding、California、美国、96001
- Shasta Orthopaedics Spine Center
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Colorado
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Parker、Colorado、美国、80134
- Denver-Vail Orthopedics, P.C.
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Connecticut
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New Britain、Connecticut、美国、28204
- Central Connecticut Neurosurgery and Spine
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Kansas
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Kansas City、Kansas、美国、66160
- Kansas University Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48109-5338
- University of Michigan, A. Alfred Taubman Health Care Center
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Nevada
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Las Vegas、Nevada、美国、89109
- Western Regional Center for Spine and Brain Surgery
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North Carolina
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Charlotte、North Carolina、美国、28204
- Carolina NeuroSurgery & Spine
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Raleigh、North Carolina、美国、27607
- Triangle Neurosurgery
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Jefferson Medical College
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Texas
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The Woodlands、Texas、美国、77381
- Greater Houston Neurosurgery Center
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Virginia
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Reston、Virginia、美国、20190
- The Virginia Spine Institute
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Richmond、Virginia、美国、23226
- Tuckahoe Orthopaedic Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Symptomatic cervical degenerative disc disease at up to four levels between C3 and T1
- Neck and/or arm pain and/or a functional neurological deficit, and/or cervical myelopathy with neural compression confirmed by plain x-rays and MRI, Myelogram or CT. Scheduled for an ACDF with a spacer and anterior supplemental fixation of the surgeon's choice.
- Greater than 18 years of age
- Unresponsive to conservative care over a period of at least 6 weeks or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention.
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent.
Exclusion Criteria:
- More than 4 levels (C3 - T1) requiring surgical treatment
- Active local or systemic infection
- Currently pregnant or considering becoming pregnant during the follow-up period
- Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year.
- Axial neck pain as the primary diagnosis, without evidence of neural compression
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution in and around the interbody spacer
- Use of adjunctive post-operative stimulation
- Prior interbody surgery at the same level
- Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Fusion Rates for Trinity Evolution
大体时间:Operative to 12 months Follow-up
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Operative to 12 months Follow-up
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次要结果测量
结果测量 |
大体时间 |
---|---|
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
大体时间:Pre-operative to 12 months follow-up
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Pre-operative to 12 months follow-up
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Complication Rates for Trinity Evolution
大体时间:Operative to 12 months follow-up
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Operative to 12 months follow-up
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合作者和调查者
调查人员
- 研究主任:Raymond J Linovitz, MD、Orthofix Spinal Implants
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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