Status:
COMPLETED
Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease
Lead Sponsor:
Synthes USA HQ, Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnai...
Detailed Description
This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using th...
Eligibility Criteria
Inclusion
- One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:
- disc herniation
- axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis
- functional deficit
- neurological deficit which significantly limits patient's normal living
- One to four cervical levels to be plated
- Patient is skeletally mature and at least 18 years of age
- Patient signs consent form
- Patient is available for long term (24 month) follow-up
- Etiology must be confirmed by MRI or CT
Exclusion
- Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
- Indications for complete corpectomy of any involved levels
- Posterior instrumentation is necessary at same levels
- More than one previous failed anterior fusion attempt at the involved level(s)
- Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.
- Pregnant or interested in becoming pregnant during the study follow-up period
- Has a known sensitivity to device materials
- Mentally incompetent or prisoner
- Currently a participant in a study related to the treatment of cervical spinal disorders
- Pre-op instability\>3mm on flexion/extension X-rays
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00443547
Start Date
March 1 2006
End Date
April 1 2011
Last Update
July 29 2019
Active Locations (13)
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1
Roderick Sanden, MD
Carmichael, California, United States, 95608
2
Yu-Po Lee, MD
La Jolla, California, United States, 92093-0706
3
Ardavan Aslie, MD
Marysville, California, United States, 95901
4
Barry Chehrazi, MD
Roseville, California, United States, 95661