Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System (VueLock)

Zimmer Biomet

Status: Completed

Conditions: Degenerative Disc Disease; Trauma; Pseudarthrosis; Scoliosis; Tumor

Treatments: Device: VueLock™ Anterior Cervical Plate

Study type: Observational

Funder types: Industry

Identifiers

NCT00726128

CP-005-04

Details and patient eligibility

About

To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Full 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.

Enrollment: 371 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

371 participants in 1 patient group

VueLock™ Anterior Cervical Plate Group

Description:

VueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)

Treatment:

Device: VueLock™ Anterior Cervical Plate