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

Degenerative Disc Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443547
• Other study ID #: VECTR 1492
• Status: Completed
• Start date: March 1, 2006
• Est. completion date: April 1, 2011

Study information

• Verified date: June 2019
• Source: Synthes USA HQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: April 1, 2011
• Est. primary completion date: April 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Roderick Sanden, MD	Carmichael	California
United States	Abhay Varma, MD	Charleston	South Carolina
United States	Faheem Sandhu, MD	Clinton	Maryland
United States	John Moriarity, MD	Flowood	Mississippi
United States	Mark Crawford, MD	Fort Wayne	Indiana
United States	Chris Urban, MD	Glen Burnie	Maryland
United States	Jamal Taha, MD	Kettering	Ohio
United States	Yu-Po Lee, MD	La Jolla	California
United States	Ardavan Aslie, MD	Marysville	California
United States	Dennis Maiman, MD	Milwaukee	Wisconsin
United States	Don Kovalsky, MD	Mount Vernon	Illinois
United States	Barry Chehrazi, MD	Roseville	California
United States	Daniel Nehls, MD	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Synthes USA HQ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Fusion	Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels	24 Months
Primary	Radiographic Fusion	Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels	12 Months
Secondary	Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score	Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst	24 Months