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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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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California
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Encinitas, California, Verenigde Staten, 92024
- CORE Orthopaedic Medical Center
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Redding, California, Verenigde Staten, 96001
- Shasta Orthopaedics Spine Center
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Colorado
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Parker, Colorado, Verenigde Staten, 80134
- Denver-Vail Orthopedics, P.C.
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Connecticut
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New Britain, Connecticut, Verenigde Staten, 28204
- Central Connecticut Neurosurgery and Spine
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Kansas University Medical Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-5338
- University of Michigan, A. Alfred Taubman Health Care Center
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89109
- Western Regional Center for Spine and Brain Surgery
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Carolina NeuroSurgery & Spine
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Raleigh, North Carolina, Verenigde Staten, 27607
- Triangle Neurosurgery
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Jefferson Medical College
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Texas
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The Woodlands, Texas, Verenigde Staten, 77381
- Greater Houston Neurosurgery Center
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Virginia
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Reston, Virginia, Verenigde Staten, 20190
- The Virginia Spine Institute
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Richmond, Virginia, Verenigde Staten, 23226
- Tuckahoe Orthopaedic Associates
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Fusion Rates for Trinity Evolution
Tijdsspanne: Operative to 12 months Follow-up
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Operative to 12 months Follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Tijdsspanne: 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
Tijdsspanne: Operative to 12 months follow-up
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Operative to 12 months follow-up
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Raymond J Linovitz, MD, Orthofix Spinal Implants
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CP-01005A
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Degeneratieve schijfziekte
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Kyorin UniversityVoltooid