- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00389597
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Study Overview
Status
Conditions
Intervention / Treatment
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 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 Design Rationale
The study is a prospective, randomized, multi-center, concurrently controlled investigation, in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion (ACDF) in accordance with the Smith-Robinson procedure. Patients will be followed for two years postsurgery (primary endpoint) and at 3, 4, 5, and 7 years thereafter.
Duration of the Investigation
Patients will be followed post-operatively at 6 weeks, and 3-, 6-, 12-, 18-, and 24-months. After 24 months, patients will continue to be followed at 3,4, 5 and 7 years.
Design Techniques to Avoid Bias
To eliminate selection bias, investigational and control comparison groups will be assigned at random.
Institutional Review Board
No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board (IRB) affiliated with the study center.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85015
- Texas Back Institute-West
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California
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Escondido, California, United States, 92122
- Southern California Institute of Neurological Surgery
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Laguna Hills, California, United States, 92653
- Massoudi & Jackson Neurosurgical Association
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Long Beach, California, United States, 90806
- Memorial Orthopaedic Surgical Group
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Rancho Mirage, California, United States, 92270
- Eisenhower Medical Center
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Sacramento, California, United States, 95817
- University of California- Davis Medical Center
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Santa Monica, California, United States, 90404
- Spine Institute at St. John's Health Center
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Stanford, California, United States, 94305
- Stanford University
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Colorado
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Golden, Colorado, United States, 80401
- Panorama Orthopedics and Spine Care
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Florida
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Orlando, Florida, United States, 32804
- Southeastern Clinical Research
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Indiana
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Fort Wayne, Indiana, United States, 46825
- Orthopaedics North East
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Spine Institute of Louisiana
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Maryland
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Baltimore, Maryland, United States, 21204
- GBMC Healthcare
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Michigan
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Detroit, Michigan, United States, 48201
- University Neurologic Systems
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Saginaw, Michigan, United States, 48604
- St. Mary's of Saginaw Field Neurosciences Institute
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New York
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Buffalo, New York, United States, 14201
- Simmons Orthopaedics and Spine Associates
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Melville, New York, United States, 11747
- Orthopedic Spine Care of Long Island
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Ohio
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic
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Oklahoma
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Tulsa, Oklahoma, United States, 74132
- Oklahoma Spine & Brain Institute
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Texas
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Austin, Texas, United States, 78701
- Austin Brain and Spine
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Houston, Texas, United States, 77401
- Foundation Surgical Hospital
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Odessa, Texas, United States, 79761
- West Texas Spine
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Plano, Texas, United States, 75093
- Texas Back Institute
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Tyler, Texas, United States, 75701
- Texas Spine and Joint Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Level
Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level
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Cervical artificial disc mechanical device
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Experimental: 2 Level
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
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Cervical artificial disc mechanical device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Definition of Study Success
Time Frame: 2 Years
|
An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:
|
2 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ralph Rashbaum, MD, Texas Back Institute
Publications and helpful links
General Publications
- Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum R, Stokes J. Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. Int J Spine Surg. 2014 Dec 1;8:7. doi: 10.14444/1007. eCollection 2014.
- Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
- Radcliff K, Davis RJ, Hisey MS, Nunley PD, Hoffman GA, Jackson RJ, Bae HW, Albert T, Coric D. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(c) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017 Nov 28;11(4):31. doi: 10.14444/4031. eCollection 2017.
- Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25. Erratum In: J Neurosurg Spine. 2016 Aug;25(2):280.
- Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016 May;24(5):734-45. doi: 10.3171/2015.8.SPINE15219. Epub 2016 Jan 22.
- Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO 3rd, Gordon C, Stone MB. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. 2015 Jan;22(1):15-25. doi: 10.3171/2014.7.SPINE13953.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LDR-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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