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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00726128
First received: July 29, 2008
Last updated: March 14, 2016
Last verified: February 2012
  Purpose
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Condition Intervention
Trauma
Tumor
Pseudarthrosis
Scoliosis
Degenerative Disc Disease
Device: VueLock™ Anterior Cervical Plate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Proportion of Patients with radiographic fusion [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neck Disability Index and SF-36 scores, change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: August 1998
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VueLock™ Anterior Cervical Plate Group
VueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF
Device: VueLock™ Anterior Cervical Plate
Implanted in subjects having an ACDF

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects from multiple centers with disease of the cervical spine
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726128

Locations
United States, California
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Alvarado Orthopedic Clinic
San Diego, California, United States, 92120
United States, Indiana
American health Network
Avon, Indiana, United States, 46234
United States, North Carolina
Raliegh Orthopedic Research Foundation
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Chair: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00726128     History of Changes
Other Study ID Numbers: CS-005 
Study First Received: July 29, 2008
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Biomet, Inc.:
DDD

Additional relevant MeSH terms:
Scoliosis
Intervertebral Disc Degeneration
Pseudarthrosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on December 08, 2016