Status:
COMPLETED
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
Lead Sponsor:
Zimmer Biomet
Conditions:
Trauma
Tumor
Eligibility:
All Genders
Brief Summary
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
Detailed Description
The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.
Eligibility Criteria
Inclusion
- The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
- The patient must be available for follow-up during the study.
- The patient must be skeletally mature (epiphyses closed).
Exclusion
- Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
- Pregnant or nursing females.
- Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.
Key Trial Info
Start Date :
August 1 1998
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00726128
Start Date
August 1 1998
End Date
September 1 2009
Last Update
February 24 2020
Active Locations (4)
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1
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
2
Alvarado Orthopedic Clinic
San Diego, California, United States, 92120
3
American health Network
Avon, Indiana, United States, 46234
4
Raliegh Orthopedic Research Foundation
Raleigh, North Carolina, United States, 27612