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OpenTrials
Completed

NCT Number: NCT00726128

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Medical Foundation, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VueLock™ Anterior Cervical Plate

Device

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

Primary outcomes

  1. Proportion of Patients with radiographic fusion

    Time frame: 24 Months

Secondary outcomes

  1. Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline

    Time frame: 24 Month

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Acronym: VueLock

Important dates

Study start
1998
Primary completion
2009
Study completion
2009
First posted
Jul 31, 2008
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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