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

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
1-level	Vectra-T	Patients needing a single level cervical fusion with Vectra-T
2-level	Vectra-T	Patients needing cervical fusion at two consecutive levels with Vectra-T
3-level	Vectra-T	Patients needing cervical fusion at three consecutive levels with Vectra-T
4-level	Vectra-T	Patients needing cervical fusion at four consecutive levels with Vectra-T

Primary Outcome Measures

Name	Time	Method
Radiographic Fusion	12 Months	Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

Secondary Outcome Measures

Name	Time	Method
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	24 Months	Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst

Locations (13): Chris Urban, MD
🇺🇸
Glen Burnie, Maryland, United States
Yu-Po Lee, MD
🇺🇸
La Jolla, California, United States
John Moriarity, MD
🇺🇸
Flowood, Mississippi, United States
Abhay Varma, MD
🇺🇸
Charleston, South Carolina, United States
Roderick Sanden, MD
🇺🇸
Carmichael, California, United States
Jamal Taha, MD
🇺🇸
Kettering, Ohio, United States
Dennis Maiman, MD
🇺🇸
Milwaukee, Wisconsin, United States
Mark Crawford, MD
🇺🇸
Fort Wayne, Indiana, United States
Ardavan Aslie, MD
🇺🇸
Marysville, California, United States
Barry Chehrazi, MD
🇺🇸
Roseville, California, United States
Faheem Sandhu, MD
🇺🇸
Clinton, Maryland, United States
Don Kovalsky, MD
🇺🇸
Mount Vernon, Illinois, United States
Daniel Nehls, MD
🇺🇸
Tacoma, Washington, United States