- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00951938
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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California
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Encinitas, California, Forente stater, 92024
- CORE Orthopaedic Medical Center
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Redding, California, Forente stater, 96001
- Shasta Orthopaedics Spine Center
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Colorado
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Parker, Colorado, Forente stater, 80134
- Denver-Vail Orthopedics, P.C.
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Connecticut
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New Britain, Connecticut, Forente stater, 28204
- Central Connecticut Neurosurgery and Spine
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- Kansas University Medical Center
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-5338
- University of Michigan, A. Alfred Taubman Health Care Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Western Regional Center for Spine and Brain Surgery
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Carolina NeuroSurgery & Spine
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Raleigh, North Carolina, Forente stater, 27607
- Triangle Neurosurgery
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Jefferson Medical College
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Texas
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The Woodlands, Texas, Forente stater, 77381
- Greater Houston Neurosurgery Center
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Virginia
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Reston, Virginia, Forente stater, 20190
- The Virginia Spine Institute
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Richmond, Virginia, Forente stater, 23226
- Tuckahoe Orthopaedic Associates
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Fusion Rates for Trinity Evolution
Tidsramme: Operative to 12 months Follow-up
|
Operative to 12 months Follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Tidsramme: Pre-operative to 12 months follow-up
|
Pre-operative to 12 months follow-up
|
Complication Rates for Trinity Evolution
Tidsramme: Operative to 12 months follow-up
|
Operative to 12 months follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Raymond J Linovitz, MD, Orthofix Spinal Implants
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP-01005A
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