LDR Spine USA Mobi-C® Cervical Disc Prosthesis IDE

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.

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study Official Title: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Ages Eligible for Study: 18 Years to 69 Years
Genders Eligible for Study: Both

Criteria

Inclusion Criteria:
1. Age 18-69 years.

2. 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:

3. Symptomatic at one or two adjacent levels from C3 to C7;

4. 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;

5. Neck Disability Index Score of greater than or equal to 15/50 or ?30%;

6. 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

Exclusion Criteria:
1. Reported to have an active systemic infection or infection at the operative site;

2. Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C;

3. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic “spontaneous” fusions;

4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury;

5. Reported to have had any prior spine surgery at the operative level;

6. Reported to have had prior cervical fusion procedure at any level;

7. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention;

8. 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;

9. Radiographic confirmation of severe facet joint disease or degeneration;

Note: Not a complete listing

Location and Contact Information

Locations

Sponsors and Collaborators: LDR Spine USA

More Information

Study ID Numbers: LDR-001, IDE Number G050212
First Received: October 18, 2006
Last Updated: October 18, 2006
ClinicalTrials.gov Identifier: NCT00389597
Health Authority: United States: Food and Drug Administration

Placed in Categories: Spinal Diseases

ClinicalTrials.gov processed this record on October 22, 2007