CompletedNot Applicable

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

United States371 participantsStarted 1998-08

Plain-language summary

To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of Patients with radiographic fusion

Timeframe: 24 Months

Trial details

NCT IDNCT00726128

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2009-09

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