Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease

NCT ID: NCT00443547

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 231 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-01
• Study Completion Date: 2011-04-01

Brief Summary

The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.

Detailed Description

This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company (Paoli, PA). This is not an investigational study (IDE) and no investigational or experimental devices or procedures are included in this study.

Conditions

Degenerative Disc Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1-level

Patients needing a single level cervical fusion with Vectra-T

Vectra-T

Intervention Type: DEVICE

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

2-level

Patients needing cervical fusion at two consecutive levels with Vectra-T

Vectra-T

Intervention Type: DEVICE

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

3-level

Patients needing cervical fusion at three consecutive levels with Vectra-T

Vectra-T

Intervention Type: DEVICE

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

4-level

Patients needing cervical fusion at four consecutive levels with Vectra-T

Vectra-T

Intervention Type: DEVICE

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

Interventions

Vectra-T

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

Intervention Type: DEVICE

Other Intervention Names

Vectra-T Translational Plating System

Eligibility Criteria

Inclusion Criteria

• One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:

• disc herniation
• axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis
• functional deficit
• neurological deficit which significantly limits patient's normal living
• One to four cervical levels to be plated
• Patient is skeletally mature and at least 18 years of age
• Patient signs consent form
• Patient is available for long term (24 month) follow-up
• Etiology must be confirmed by MRI or CT

Exclusion Criteria

• Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
• Indications for complete corpectomy of any involved levels
• Posterior instrumentation is necessary at same levels
• More than one previous failed anterior fusion attempt at the involved level(s)
• Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.
• Pregnant or interested in becoming pregnant during the study follow-up period
• Has a known sensitivity to device materials
• Mentally incompetent or prisoner
• Currently a participant in a study related to the treatment of cervical spinal disorders
• Pre-op instability>3mm on flexion/extension X-rays

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald Kovalsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

Roderick Sanden, MD

Carmichael, California, United States

Yu-Po Lee, MD

La Jolla, California, United States

Ardavan Aslie, MD

Marysville, California, United States

Barry Chehrazi, MD

Roseville, California, United States

Don Kovalsky, MD

Mount Vernon, Illinois, United States

Mark Crawford, MD

Fort Wayne, Indiana, United States

Faheem Sandhu, MD

Clinton, Maryland, United States

Chris Urban, MD

Glen Burnie, Maryland, United States

John Moriarity, MD

Flowood, Mississippi, United States

Jamal Taha, MD

Kettering, Ohio, United States

Abhay Varma, MD

Charleston, South Carolina, United States

Daniel Nehls, MD

Tacoma, Washington, United States

Dennis Maiman, MD

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

VECTR 1492

Identifier Type: -

Identifier Source: org_study_id