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A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System


N/A
N/A
N/A
Not Enrolling
Both
Trauma, Tumor, Pseudarthrosis, Scoliosis, Degenerative Disc Disease

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Trial Information

A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Proportion of Patients with radiographic fusion

Outcome Time Frame:

24 Months

Safety Issue:

No

Principal Investigator

John Evangelsita, MD

Investigator Role:

Study Chair

Investigator Affiliation:

EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

Authority:

United States: Institutional Review Board

Study ID:

CS-005

NCT ID:

NCT00726128

Start Date:

August 1998

Completion Date:

September 2009

Related Keywords:

  • Trauma
  • Tumor
  • Pseudarthrosis
  • Scoliosis
  • Degenerative Disc Disease
  • DDD
  • Pseudarthrosis
  • Scoliosis
  • Intervertebral Disk Degeneration

Name

Location

Palo Alto Medical FoundationPalo Alto, California  94301
American Health NetworkIndianapolis, Indiana  46202
Alvarado Orthopedic ClinicSan Diego, California  92120
Raliegh Orthopedic Research FoundationRaleigh, North Carolina  27612