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

This study has been completed.

Sponsor:

Information provided by:

Synthes USA HQ, Inc.

ClinicalTrials.gov Identifier:

NCT00443547

First received: March 2, 2007

Last updated: July 1, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2007

Last Updated Date

July 1, 2011

Start Date ^ICMJE

March 2006

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Radiographic Fusion [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00443547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Multi-Center Clinical Study of Patients With Degenerative Disc Disease Treated With Anterior Cervical Decompression and Fusion Using the Vectra-T Translational Cervical Plate.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Degenerative Disc Disease

Intervention ^ICMJE

Device: Anterior Cervical Discectomy and Fusion (ACDF)

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

Other Name: Vectra-T Translational Plating System

Study Arm (s)

1-level
Patients needing a single level cervical fusion

Intervention: Device: Anterior Cervical Discectomy and Fusion (ACDF)
2-level
Patients needing cervical fusion at two consecutive levels

Intervention: Device: Anterior Cervical Discectomy and Fusion (ACDF)
3-level
Patients needing cervical fusion at three consecutive levels

Intervention: Device: Anterior Cervical Discectomy and Fusion (ACDF)
4-level
Patients needing cervical fusion at four consecutive levels

Intervention: Device: Anterior Cervical Discectomy and Fusion (ACDF)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

231

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00443547

Other Study ID Numbers ^ICMJE

VECTR 1492

Has Data Monitoring Committee

Responsible Party

Damon Lees, Clinical Regulatory Manager, Spine Global Regulatory & Clinical Affairs, Synthes USA HQ. Inc.

Study Sponsor ^ICMJE

Synthes USA HQ, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Donald Kovalsky, M.D.

Information Provided By

Synthes USA HQ, Inc.

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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