Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Completed · Phase 3

Conditions studied: Cervical Degenerative Disc Disease

In brief

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Key facts

Study ID

NCT00667459

Run by

Medtronic Spinal and Biologics

People needed

280

Starts

2005-01-01

Expected to finish

2014-06-01

Last updated by the study team

2023-06-06

Who can join

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

You may qualify if…

• Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
• One level requiring surgical treatment
• C3-C4 disc to C6-C7 disc level involvement
• Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
• No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
• Preop Neck Disability index score ≥ 30
• Preop Neck Pain score of ≥ 20 based on the Preop Neck \& Arm Pain Questionnaire
• Not pregnant at time of surgery
• Willing and able to comply with study plan and able to understand and sign patient informed consent

You may not qualify if…

• Any other cervical spinal condition requiring surgical treatment at the involved level
• Documented or diagnosed cervical instability defined by radiographs showing
• Sagittal plane translation > 3.5mm or
• Sagittal plane angulation > 20 degrees.
• More than one cervical level requiring surgery
• A fused level adjacent to the level to be treated
• Severe pathology of the facet joint of involved bodies
• Previous surgery at the involved level
• Previously diagnosed osteopenia or osteomalacia
• Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
• Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
• Male over the age of 70
• Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
• If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.
• Presence of spinal metastases
• Overt or active bacterial infection, either local or systemic
• Severe insulin dependent diabetes
• Chronic or acute renal failure or history of renal disease
• Temperature > 101º F oral at surgery
• Documented allergy to stainless steel, titanium or a titanium alloy
• Mentally incompetent
• Is a prisoner
• Is pregnant
• Is an alcohol and/or drug abuser

Where it is running

• Emory Orthopaedics and Spine Center — Atlanta, Georgia, United States
• The Hughston Clinic, P.C. — Columbus, Georgia, United States
• Coeur d'Alene Spine and Brain, PLLC — Coeur d'Alene, Idaho, United States
• Central Illinois Neuroscience — Bloomington, Illinois, United States
• Indiana Spine — Carmel, Indiana, United States
• OrthoIndy — Indianapolis, Indiana, United States
• Cedar Neurological Surgeons, PC — Cedar Rapids, Iowa, United States
• Sports Medicine North — Peabody, Massachusetts, United States
• The Orthopaedic Center of St. Louis — Chesterfield, Missouri, United States
• Springfield Neurological Institute — Springfield, Missouri, United States
• Buffalo Neurosurgery Group — West Seneca, New York, United States
• NeuroSpine Institute, LLC — Eugene, Oregon, United States
• Clinical Trials for South Carolina — Charleston, South Carolina, United States
• Chattanooga Orthopaedic Group — Chattanooga, Tennessee, United States
• Brain and Spine Center of Texas, L.L.P. — Plano, Texas, United States
• University of Virginia,Neurosurgery Department — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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