A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

Zimmer Biomet4 sites in 1 country371 target enrollmentAugust 1998

ConditionsTrauma Tumor Pseudarthrosis Scoliosis Degenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Trauma
Sponsor: Zimmer Biomet
Enrollment: 371
Locations: 4
Primary Endpoint: Proportion of Patients with radiographic fusion
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1998

End Date

September 2009

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.