Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

Completed · Not applicable

Conditions studied: Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy

In brief

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

Key facts

Study ID

NCT00637156

Run by

Medtronic Spinal and Biologics

People needed

397

Starts

2006-06-01

Expected to finish

2018-02-01

Last updated by the study team

2018-05-01

Who can join

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

You may qualify if…

• Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \& involving intractable radiculopathy, myelopathy, or both
• Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
• Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
• Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
• Must be ≥ 18 years; skeletally mature at time of surgery
• Preoperative NDI score ≥ 30
• Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
• If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
• Is willing to comply with the study plan and sign Patient Informed Consent Form

You may not qualify if…

• Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
• Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.
• Has more than two cervical levels requiring surgical treatment
• Has a fused level adjacent to the levels to be treated
• Has severe pathology of the facet joints of the involved vertebral bodies
• Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels
• 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 a DEXA Scan will be required to determine eligibility.)
• Postmenopausal non-Black female over age of 60 who weighs < 140 pounds
• Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture
• Male > 70 years
• Male > 60 years who has sustained a non-traumatic hip or spine fracture
• If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower 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 insulin dependent diabetes
• Is a tobacco user who does not agree to suspend smoking prior to surgery
• Has chronic or acute renal failure or prior history of renal disease
• 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
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
• Is involved with current or pending litigation regarding a spinal condition
• Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs

Where it is running

• The Orthopaedic Center; Crestwood Medical Center — Huntsville, Alabama, United States
• Todd Lanman, MD, FACS, A Professional Corp.; — Beverly Hills, California, United States
• Bone & Spine Surgery — Colton, California, United States
• La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas — La Jolla, California, United States
• St. Mary's Spine Center; St. Mary's Hospital — San Francisco, California, United States
• Delaware Neurosurgical Group; Christiana Care Health Systems — Newark, Delaware, United States
• Spinal Associates, Gulf Coast Hospital — Panama City, Florida, United States
• Peachtree Neurosurgery, Northside Hospital — Atlanta, Georgia, United States
• The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center — Columbus, Georgia, United States
• Neuro Spine & Pain Center; Lutheran Hospital — Fort Wayne, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Great Lakes Neurosurgical; Spectrum Health East Campus — Grand Rapids, Michigan, United States
• Adams Neurosurgery; Mid Michigan Medical Center — Saginaw, Michigan, United States
• Henry Ford Hospital — West Bloomfield, Michigan, United States
• The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital — Chesterfield, Missouri, United States
• Montana Neuro Science Institute; St. Patrick's Medical Center — Missoula, Montana, United States
• University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute — Buffalo, New York, United States
• Buffalo Neurosurgery Group — West Seneca, New York, United States
• Crystal Clinic, Inc.; Akron General Medical Center — Akron, Ohio, United States
• Central Ohio Neurological Surgeons; Mt. Carmel East Hospital — Westerville, Ohio, United States
• The Center Orthopaedic & Neurosurgical Care & Research — Bend, Oregon, United States
• OAA Orthopaedic Specialists — Allentown, Pennsylvania, United States
• Allegheny Neurosurgery; Washington Hospital — Pittsburgh, Pennsylvania, United States
• Lexington Brain and Spine Institute — West Columbia, South Carolina, United States
• Center for Sports Medicine and Orthopaedics; Memorial Hospital — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.