TraumaVueLockNCT00726128
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
An observational study of Trauma and Tumor, run by Zimmer Biomet at 4 sites in United States.
Trial summary
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Tumor, Pseudarthrosis
- What is being tested?
- VueLock™ Anterior Cervical Plate
- Type of treatment
- Medical device
- How many people
- 371 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 1998to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects from multiple centers with disease of the cervical spine
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
American health Network
Avon, Indiana, 46234
Palo Alto Medical Foundation
Palo Alto, California, 94301
Raliegh Orthopedic Research Foundation
Raleigh, North Carolina, 27612
Alvarado Orthopedic Clinic
San Diego, California, 92120
About this study
Official title: 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
Read the 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.
- Conditions
- Trauma, Tumor, Pseudarthrosis, Scoliosis, Degenerative Disc Disease
- Being tested
- VueLock™ Anterior Cervical Plate
- Keywords
- Degenerative Disc disease (DDD)
- Medical subject headings
- Wounds and Injuries, Neoplasms, Pseudarthrosis, Scoliosis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VueLock™ Anterior Cervical PlateDevice
Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)
| Study group | Role | What they receive |
|---|---|---|
| VueLock™ Anterior Cervical Plate Group | VueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion) Receives: Device: VueLock™ Anterior Cervical Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with radiographic fusion
Measured: 24 Months
Secondary outcomes (1)
Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startAug 1998
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Evangelsita, MD, Study chair, EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726128
- Sponsor's protocol ID
- CP-005-04
- Acronym
- VueLock
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2008
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
- ClinicalTrials.gov ID
- NCT00726128
- Acronym / sponsor ID
- VueLock / CP-005-04
- Conditions
- Trauma, Tumor, Pseudarthrosis, Scoliosis, Degenerative Disc Disease
- Keywords
- Degenerative Disc disease (DDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VueLock™ Anterior Cervical Plate Group | – | Device: VueLock™ Anterior Cervical PlateVueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects from multiple centers with disease of the cervical spine
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VueLock™ Anterior Cervical PlateImplanted in subjects having an ACDF (Anterior cervical discectomy and fusion) | Device | VueLock™ Anterior Cervical Plate Group |
Primary outcome
Proportion of Patients with radiographic fusion
Time frame: 24 Months
1 secondary outcome
Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline
Time frame: 24 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Evangelsita, MD study chair
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Tumor, run by Zimmer Biomet at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with radiographic fusion (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.