LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.

Key facts

Study ID

NCT00389597

Run by

LDR Spine USA

People needed

599

Starts

2006-04-01

Expected to finish

2015-11-01

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-69 years.
• Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
• Neck and/or arm pain (at least 30mm on the 100mm VAS scale).
• Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
• Abnormal sensation including hyperesthesia or hypoesthesia; and/or
• Abnormal reflexes
• Symptomatic at one or two adjacent levels from C3 to C7;
• Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following:
• Decreased disc height on radiography, CT, or MRI in comparison to a normal adjacent disc.
• Degenerative spondylosis on CT or MRI.
• Disc herniation on CT or MRI;
• Neck Disability Index Score of ≥15/50 or ≥30%;
• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
• Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
• Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
• Note: Not a complete listing

You may not qualify if…

• Reported to have an active systemic infection or infection at the operative site;
• Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C;
• More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions;
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury;
• Reported to have had any prior spine surgery at the operative level;
• Reported to have had prior cervical fusion procedure at any level;
• Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention;
• Disc height less than 3mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body;
• Radiographic confirmation of severe facet joint disease or degeneration;
• Note: Not a complete listing

Where it is running

• Texas Back Institute-West — Phoenix, Arizona, United States
• Southern California Institute of Neurological Surgery — Escondido, California, United States
• Massoudi & Jackson Neurosurgical Association — Laguna Hills, California, United States
• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• University of California- Davis Medical Center — Sacramento, California, United States
• Spine Institute at St. John's Health Center — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• Panorama Orthopedics and Spine Care — Golden, Colorado, United States
• Southeastern Clinical Research — Orlando, Florida, United States
• Orthopaedics North East — Fort Wayne, Indiana, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• GBMC Healthcare — Baltimore, Maryland, United States
• University Neurologic Systems — Detroit, Michigan, United States
• St. Mary's of Saginaw Field Neurosciences Institute — Saginaw, Michigan, United States
• Simmons Orthopaedics and Spine Associates — Buffalo, New York, United States
• Orthopedic Spine Care of Long Island — Melville, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Oklahoma Spine & Brain Institute — Tulsa, Oklahoma, United States
• Austin Brain and Spine — Austin, Texas, United States
• Foundation Surgical Hospital — Houston, Texas, United States
• West Texas Spine — Odessa, Texas, United States
• Texas Back Institute — Plano, Texas, United States
• Texas Spine and Joint Hospital — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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