Status:
COMPLETED
Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
Lead Sponsor:
Orthofix Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients to measure the c...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00951938
Start Date
August 1 2009
End Date
August 1 2012
Last Update
April 8 2014
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
2
Shasta Orthopaedics Spine Center
Redding, California, United States, 96001
3
Denver-Vail Orthopedics, P.C.
Parker, Colorado, United States, 80134
4
Central Connecticut Neurosurgery and Spine
New Britain, Connecticut, United States, 28204