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NCT00726128 Clinical Trial

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

Trauma Clinical Trial

— VueLock  

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date February 2020
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome
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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