- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00726128
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
Status
Completed
Conditions
Intervention / Treatment
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
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Avon, Indiana, United States, 46234
- American Health Network
-
-
North Carolina
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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:
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-005-04
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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