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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00951938 |
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Date of registration:
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31/07/2009 |
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Primary sponsor: |
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Public title:
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Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
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Scientific title:
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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 |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00951938 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Raymond J Linovitz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthofix Spinal Implants |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Degenerative Disc Disease
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Primary Outcome(s)
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Fusion Rates for Trinity Evolution
[Time Frame: Operative to 12 months Follow-up]
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Secondary Outcome(s)
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Complication Rates for Trinity Evolution
[Time Frame: Operative to 12 months follow-up]
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NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
[Time Frame: Pre-operative to 12 months follow-up]
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Secondary ID(s)
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CP-01005A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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