PRESTIGE® Cervical Disc Study

Completed · Not applicable

Conditions studied: Degenerative Cervical Disc Disease

In brief

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Key facts

Study ID

NCT00642876

Run by

Medtronic Spinal and Biologics

People needed

541

Starts

2002-10-01

Expected to finish

2013-05-01

Last updated by the study team

2023-05-10

Who can join

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

You may qualify if…

• All patients participating in this study must meet all of the following inclusion criteria:
• Cervical degenerative disc disease defined as:
• intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., neck and/or arm pain], functional deficit, and/or neurological deficit, and radiographic studies (e.g., CT, MRI, x-rays, etc).
• herniated disc;
• osteophyte formation;
• One cervical level requiring surgical treatment;
• C3-C4 disc to C6-C7 disc level of involvement;
• Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management;
• No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s);
• Is at least 18 years of age, inclusive, at the time of surgery;
• Preoperative Neck Disability Index score > or = 30;
• Has a preoperative neck pain score of > 20 based on the Preoperative Neck and Arm Pain Questionnaire.
• If of child-bearing potential, patient is not pregnant at the time of surgery;
• Is willing to comply with the study plan and sign the Patient Informed Consent Form.

You may not qualify if…

• A patient meeting any of the following criteria is to be excluded from the study:
• Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;
• Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:
• Sagittal plane translation > 3.5 mm or;
• Sagittal plane angulation > 20.
• More than one cervical level requiring surgical treatment;
• Has a fused level adjacent to the level to be treated;
• Has severe pathology of the facet joints of the involved vertebral bodies;
• Previous surgical intervention at the involved level;
• Has been previously diagnosed with osteopenia or osteomalacia;
• Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes to any of the below risk factors, 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 BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, then the patient is excluded from the study.
• Has presence of spinal metastases;
• Has overt or active bacterial infection, either local or systemic;
• Has severe insulin dependent diabetes;
• Has chronic or acute renal failure or prior history of renal disease;
• Has fever (temperature > 101 F oral) at the time of surgery;
• Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy;
• Is mentally incompetent. (If questionable, obtain psychiatric consult);
• Is a prisoner;
• Is pregnant;

Where it is running

• North Alabama Neurological — Huntsville, Alabama, United States
• Montgomery Neurosurgical — Montgomery, Alabama, United States
• University of California, Davis — Sacramento, California, United States
• The Spine Institute — Santa Monica, California, United States
• Orlando Neurosurgery — Winter Park, Florida, United States
• Atlanta Brain and Spine Care — Atlanta, Georgia, United States
• Emory Orthop and Spine Center — Atlanta, Georgia, United States
• Hughston Clinic — Columbus, Georgia, United States
• Central Illinois Neuroscience — Bloomington, Illinois, United States
• Loyola University Medical Center — Oak Park, Illinois, United States
• Orthoindy — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Baton Rouge Orth Clinic — Baton Rouge, Louisiana, United States
• Neurosurgery Ass, P.A. — Baltimore, Maryland, United States
• Michigan Brain & Spine Institute — Ypsilanti, Michigan, United States
• The Ortho Center of St. Louis — Chesterfield, Missouri, United States
• Springfield Neurological Institute — Springfield, Missouri, United States
• Surgical Neurology New Hampshire Neurospine Institute — Bedford, New Hampshire, United States
• Buffalo Neurosurgery Group — West Seneca, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Westphal Group — Lancaster, Pennsylvania, United States
• Center of Neurosciences Orthopedics & Spine, P.C. — Dakota Dunes, South Dakota, United States
• Spine Surgery Associates — Chattanooga, Tennessee, United States
• Semmes Murphey — Memphis, Tennessee, United States
• Howell Allen Clinic — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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