Degenerative Disc Disease, Pseudarthrosis, Scoliosis, Trauma, Tumor
Conditions
Keywords
Degenerative Disc disease (DDD)
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.
Interventions
Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)
Sponsors
Study design
Eligibility
Inclusion criteria
1. 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. 2. The patient must be available for follow-up during the study. 3. The patient must be skeletally mature (epiphyses closed).
Exclusion criteria
1. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc. 2. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. 3. Pregnant or nursing females. 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients with radiographic fusion | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline | 24 Month |
Countries
United States