Trauma Clinical Trial
— VueLockOfficial title:
A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
NCT number | NCT00726128 |
Other study ID # | CP-005-04 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1998 |
Est. completion date | September 2009 |
Verified date | February 2020 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
Status | Completed |
Enrollment | 371 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | American health Network | Avon | Indiana |
United States | Palo Alto Medical Foundation | Palo Alto | California |
United States | Raliegh Orthopedic Research Foundation | Raleigh | North Carolina |
United States | Alvarado Orthopedic Clinic | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients with radiographic fusion | 24 Months | ||
Secondary | Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline | 24 Month |
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