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

February 20, 2020 updated by: Zimmer Biomet

A Multi-Center Prospective 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

Study Overview

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 Type

Observational

Enrollment (Actual)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation
      • San Diego, California, United States, 92120
        • Alvarado Orthopedic Clinic
    • Indiana
      • Avon, Indiana, United States, 46234
        • American Health Network
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Raliegh Orthopedic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects from multiple centers with disease of the cervical spine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Patients with radiographic fusion
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline
Time Frame: 24 Month
24 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: John Evangelsita, MD, EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (ESTIMATE)

July 31, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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