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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Encinitas、California、アメリカ、92024
- CORE Orthopaedic Medical Center
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Redding、California、アメリカ、96001
- Shasta Orthopaedics Spine Center
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Colorado
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Parker、Colorado、アメリカ、80134
- Denver-Vail Orthopedics, P.C.
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Connecticut
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New Britain、Connecticut、アメリカ、28204
- Central Connecticut Neurosurgery and Spine
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Kansas
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Kansas City、Kansas、アメリカ、66160
- Kansas University Medical Center
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-5338
- University of Michigan, A. Alfred Taubman Health Care Center
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Nevada
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Las Vegas、Nevada、アメリカ、89109
- Western Regional Center for Spine and Brain Surgery
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North Carolina
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Charlotte、North Carolina、アメリカ、28204
- Carolina NeuroSurgery & Spine
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Raleigh、North Carolina、アメリカ、27607
- Triangle Neurosurgery
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Jefferson Medical College
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Texas
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The Woodlands、Texas、アメリカ、77381
- Greater Houston Neurosurgery Center
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Virginia
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Reston、Virginia、アメリカ、20190
- The Virginia Spine Institute
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Richmond、Virginia、アメリカ、23226
- Tuckahoe Orthopaedic Associates
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Fusion Rates for Trinity Evolution
時間枠:Operative to 12 months Follow-up
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Operative to 12 months Follow-up
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二次結果の測定
結果測定 |
時間枠 |
---|---|
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
時間枠: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
時間枠:Operative to 12 months follow-up
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Operative to 12 months follow-up
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Raymond J Linovitz, MD、Orthofix Spinal Implants
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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