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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00726128
Acronym
VueLock
Enrollment
371
Registered
2008-07-31
Start date
1998-08-31
Completion date
2009-09-30
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Pseudarthrosis, Scoliosis, Trauma, Tumor

Keywords

Degenerative Disc disease (DDD)

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.

Interventions

DEVICEVueLock™ Anterior Cervical Plate

Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)

Sponsors

Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Proportion of Patients with radiographic fusion24 Months

Secondary

MeasureTime frame
Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline24 Month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026