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

NCT00726128 | Completed

• 1 other identifier: CP-005-04
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 4

Brief Summary

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

Keywords

Degenerative Disc disease (DDD)

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with radiographic fusion

  24 Months

Secondary Outcomes (1)

• Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline

  24 Month

Study Arms (1)

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

VueLock™ Anterior Cervical Plate DEVICE

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

VueLock™ Anterior Cervical Plate Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects from multiple centers with disease of the cervical spine

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Alvarado Orthopedic Clinic

San Diego, California, 92120, United States

Location

American health Network

Avon, Indiana, 46234, United States

Location

Raliegh Orthopedic Research Foundation

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Neoplasms; Pseudarthrosis; Scoliosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• John Evangelsita, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: July 31, 2008
• Study Start: August 1, 1998
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (4)