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

Completed

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00443547

Run by

Synthes USA HQ, Inc.

People needed

231

Starts

2006-03-01

Expected to finish

2011-04-01

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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