Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
599 participants
INTERVENTIONAL
2006-04-30
2015-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1 Level
Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level
Cervical Artificial Disc
Cervical artificial disc mechanical device
2 Level
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
Cervical Artificial Disc
Cervical artificial disc mechanical device
Interventions
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Cervical Artificial Disc
Cervical artificial disc mechanical device
Eligibility Criteria
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Inclusion Criteria
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:
* 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
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 ≥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
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
18 Years
69 Years
ALL
No
Sponsors
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LDR Spine USA
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph Rashbaum, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Back Institute
Locations
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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
Countries
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References
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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.
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.
Related Links
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FDA Approval 2 Level
FDA Approval 1 Level
Other Identifiers
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LDR-001
Identifier Type: -
Identifier Source: org_study_id