NCT00443547

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 231 (actual)
• Sponsor: Synthes USA HQ, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Vectra-T	Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

Timeline

• Start date: 2006-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2007-03-06
• Last updated: 2019-07-29
• Results posted: 2019-07-29

Locations

13 sites across 1 country: United States