Clinical trial NCT00389597: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Official title: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: degenerative disc disease
cervical arthroplasty
Mobi C
multilevel
anterior cervical discectomy and fusion
Lead sponsor: LDR Spine USA
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility 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:

   * 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:

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

Primary outcomes:
measure: Composite Definition of Study Success
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Texas Back Institute-West
state: Arizona
city: Escondido
country: United States
facility: Southern California Institute of Neurological Surgery
state: California
city: Laguna Hills
country: United States
facility: Massoudi & Jackson Neurosurgical Association
state: California
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Sacramento
country: United States
facility: University of California- Davis Medical Center
state: California
city: Santa Monica
country: United States
facility: Spine Institute at St. John's Health Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Golden
country: United States
facility: Panorama Orthopedics and Spine Care
state: Colorado
city: Orlando
country: United States
facility: Southeastern Clinical Research
state: Florida
city: Fort Wayne
country: United States
facility: Orthopaedics North East
state: Indiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: GBMC Healthcare
state: Maryland
city: Detroit
country: United States
facility: University Neurologic Systems
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Saginaw Field Neurosciences Institute
state: Michigan
city: Buffalo
country: United States
facility: Simmons Orthopaedics and Spine Associates
state: New York
city: Melville
country: United States
facility: Orthopedic Spine Care of Long Island
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Spine & Brain Institute
state: Oklahoma
city: Austin
country: United States
facility: Austin Brain and Spine
state: Texas
city: Houston
country: United States
facility: Foundation Surgical Hospital
state: Texas
city: Odessa
country: United States
facility: West Texas Spine
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Tyler
country: United States
facility: Texas Spine and Joint Hospital
state: Texas
Study officials:
affiliation: Texas Back Institute
name: Ralph Rashbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.