LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

• ClinicalTrials.gov Identifier: NCT00389597
• Recruitment Status: Completed
• First Posted: October 19, 2006
• Results First Posted: May 1, 2014
• Last Update Posted: December 11, 2017
• Sponsor: LDR Spine USA
• Information provided by (Responsible Party): LDR Spine USA

Tracking Information

• First Submitted Date: October 18, 2006
• First Posted Date: October 19, 2006
• Results First Submitted Date: January 3, 2014
• Results First Posted Date: May 1, 2014
• Last Update Posted Date: December 11, 2017
• Study Start Date: April 2006
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2014)

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:

• Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.
• No study failures due to secondary surgical interventions at the index level
• Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
• Official Title: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Degenerative Disc Disease

Intervention

Device: Cervical Artificial Disc

Cervical artificial disc mechanical device

Study Arms

• Experimental: 1 Level
  Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level
  Intervention: Device: Cervical Artificial Disc
• Experimental: 2 Level
  Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
  Intervention: Device: Cervical Artificial Disc

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. 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© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017 Nov 28;11:31. 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 1, 2014): 599
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00389597
• Other Study ID Numbers: LDR-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: LDR Spine USA
• Study Sponsor: LDR Spine USA
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ralph Rashbaum, MD; Texas Back Institute

• PRS Account: LDR Spine USA
• Verification Date: November 2017