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

Completed

• Conditions: Tumor; Degenerative Disc Disease; Pseudarthrosis; Scoliosis; Trauma
• Interventions: Device: VueLock™ Anterior Cervical Plate

• Registration Number: NCT00726128
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Patients with radiographic fusion	24 Months

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline	24 Month

Trial Locations

Locations (4)

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

Alvarado Orthopedic Clinic; 🇺🇸 San Diego, California, United States

American health Network; 🇺🇸 Avon, Indiana, United States

Raliegh Orthopedic Research Foundation; 🇺🇸 Raleigh, North Carolina, United States