Status:
COMPLETED
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
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 posterior fixation of the surgeon's choice and to follow the patients to measure the ...
Detailed Description
Degenerative disorders of the lumbar spine can lead to a multitude of clinical problems including back pain and/or leg pain secondary to nerve compression and/or deformity. When conservative (non-surg...
Eligibility Criteria
Inclusion
- Symptomatic lumbar degenerative disc disease at 1 or 2 adjacent levels between L3 and S1
- Patients with back and/or leg pain scheduled for stabilization with or without decompression via a TLIF or PLIF approach utilizing an interbody spacer and supplemental posterior fixation.
- Greater than 18 years of age
- Unresponsive to conservative care over a period of at least 6 months 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
- Patients requiring surgical treatment other than at 1 or 2 adjacent levels between L3 and S1
- 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
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution matrix 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 :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00965380
Start Date
September 1 2009
End Date
January 1 2015
Last Update
October 23 2018
Active Locations (15)
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1
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
2
Total Spine Care
Canton, Connecticut, United States, 06019
3
Middlesex Orthopedic Surgeons
Middletown, Connecticut, United States, 06457
4
Center for Advanced Neuro and Spine
New Britain, Connecticut, United States, 06051