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CompletedNCT00726128VueLockUpdated Feb 24, 2020

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

An observational study in Trauma, Tumor and Pseudarthrosis, sponsored by Zimmer Biomet. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2020-02-24.

Primary conditionPseudarthrosisRegistry: Wounds and InjuriesReclassifiedWhy we changed it
Registry
Wounds and Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pseudarthrosis
Why
  1. The study's listed conditions name Pseudarthrosis, a narrower term within Wounds and Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Zimmer Biomet · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
371
Sex
All
01

Study 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 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.

02

Conditions studied

  • Trauma
  • Tumor
  • Pseudarthrosis
  • Scoliosis
  • Degenerative Disc Disease

Keywords

  • Degenerative Disc disease (DDD)
03

In context

Pseudarthrosis Reclassified

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's enrollment of 371 is above the median of 60 across 16 observational studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Browse Zimmer Biomet studies →

Compared within Pseudarthrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects from multiple centers with disease of the cervical spine

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
371 participants (actual)

Groups and cohorts

  • VueLock™ Anterior Cervical Plate Group

    VueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)

    Device: VueLock™ Anterior Cervical Plate

Interventions

  • DeviceVueLock™ Anterior Cervical Plate

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

06

What researchers measure

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

07

Study locations

4 sites
  • Palo Alto Medical Foundation
    Palo Alto, California 94301, United States
  • Alvarado Orthopedic Clinic
    San Diego, California 92120, United States
  • American health Network
    Avon, Indiana 46234, United States
  • Raliegh Orthopedic Research Foundation
    Raleigh, North Carolina 27612, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 1998, a primary completion of Sep 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2008
First posted
Jul 31, 2008
Start
Aug 1998
Primary completionActual
Sep 2009
CompletionActual
Sep 2009
Last update
Feb 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00726128
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Jul 31, 2008
Start date
Aug 1998
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Feb 24, 2020

Study contacts

John Evangelsita, MD
study chair · EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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