- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
California
-
Encinitas, California, Vereinigte Staaten, 92024
- CORE Orthopaedic Medical Center
-
Redding, California, Vereinigte Staaten, 96001
- Shasta Orthopaedics Spine Center
-
-
Colorado
-
Parker, Colorado, Vereinigte Staaten, 80134
- Denver-Vail Orthopedics, P.C.
-
-
Connecticut
-
New Britain, Connecticut, Vereinigte Staaten, 28204
- Central Connecticut Neurosurgery and Spine
-
-
Kansas
-
Kansas City, Kansas, Vereinigte Staaten, 66160
- Kansas University Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Vereinigte Staaten, 48109-5338
- University of Michigan, A. Alfred Taubman Health Care Center
-
-
Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89109
- Western Regional Center for Spine and Brain Surgery
-
-
North Carolina
-
Charlotte, North Carolina, Vereinigte Staaten, 28204
- Carolina NeuroSurgery & Spine
-
Raleigh, North Carolina, Vereinigte Staaten, 27607
- Triangle Neurosurgery
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Jefferson Medical College
-
-
Texas
-
The Woodlands, Texas, Vereinigte Staaten, 77381
- Greater Houston Neurosurgery Center
-
-
Virginia
-
Reston, Virginia, Vereinigte Staaten, 20190
- The Virginia Spine Institute
-
Richmond, Virginia, Vereinigte Staaten, 23226
- Tuckahoe Orthopaedic Associates
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Fusion Rates for Trinity Evolution
Zeitfenster: Operative to 12 months Follow-up
|
Operative to 12 months Follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Zeitfenster: Pre-operative to 12 months follow-up
|
Pre-operative to 12 months follow-up
|
Complication Rates for Trinity Evolution
Zeitfenster: Operative to 12 months follow-up
|
Operative to 12 months follow-up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Raymond J Linovitz, MD, Orthofix Spinal Implants
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CP-01005A
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Degenerative Bandscheibenerkrankungen
-
Ege UniversityAbgeschlossen
-
Shanghai Eye Disease Prevention and Treatment CenterNoch keine RekrutierungKurzsichtigkeit, progressiv
-
Beijing Airdoc Technology Co., Ltd.Rekrutierung
-
Shanghai Eye Disease Prevention and Treatment CenterRekrutierungKurzsichtigkeit, progressivChina
-
Beijing Airdoc Technology Co., Ltd.The First People's Hospital of XuzhouRekrutierungKurzsichtigkeit, progressivChina
-
Universidad Complutense de MadridCooperativa de Ensino Superior, Politécnico e Universitário; Novovision; Instituto... und andere MitarbeiterAktiv, nicht rekrutierend
-
Nova Southeastern UniversityZurückgezogenKurzsichtigkeit, progressiv
-
National Taiwan University HospitalUnbekannt
-
Shanghai Eye Disease Prevention and Treatment CenterRekrutierungKurzsichtigkeit, progressivChina
-
Shanghai Eye Disease Prevention and Treatment CenterShanghai General Hospital, Shanghai Jiao Tong University School of MedicineNoch keine RekrutierungKurzsichtigkeitsprävention durch Überwachung und Motivation von Outdoor-Aktivitäten mit SmartwatchesKurzsichtigkeit, progressiv