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

Study Overview
=================
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.

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.

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: Vectra-T


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-level<br>Patients needing a single level cervical fusion with Vectra-T | Device: Vectra-T<br>* Patient will receive the Vectra-T plate (Sized 1 to 4 levels)<br>* Other names: Vectra-T Translational Plating System;|
| 2-level<br>Patients needing cervical fusion at two consecutive levels with Vectra-T | Device: Vectra-T<br>* Patient will receive the Vectra-T plate (Sized 1 to 4 levels)<br>* Other names: Vectra-T Translational Plating System;|
| 3-level<br>Patients needing cervical fusion at three consecutive levels with Vectra-T | Device: Vectra-T<br>* Patient will receive the Vectra-T plate (Sized 1 to 4 levels)<br>* Other names: Vectra-T Translational Plating System;|
| 4-level<br>Patients needing cervical fusion at four consecutive levels with Vectra-T | Device: Vectra-T<br>* Patient will receive the Vectra-T plate (Sized 1 to 4 levels)<br>* Other names: Vectra-T Translational Plating System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | 24 Months | 
| Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prospective, Degenerative Disc Disease, Cervical, Translational Plate