Status:
COMPLETED
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Lead Sponsor:
LDR Spine USA
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Objectives of the Investigation 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 interbod...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00389597
Start Date
April 1 2006
End Date
November 1 2015
Last Update
December 11 2017
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Back Institute-West
Phoenix, Arizona, United States, 85015
2
Southern California Institute of Neurological Surgery
Escondido, California, United States, 92122
3
Massoudi & Jackson Neurosurgical Association
Laguna Hills, California, United States, 92653
4
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806