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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA
ClinicalTrials.gov Identifier:
NCT00389597
First received: October 18, 2006
Last updated: October 14, 2012
Last verified: October 2012

October 18, 2006
October 14, 2012
April 2006
March 2010   (final data collection date for primary outcome measure)
Composite definition of Study Success [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00389597 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

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.

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.

A maximum of 25 centers will participate in the study. Enrollment will be monitored to ensure that each center performs an adequate number of cases and no one center contributes a disproportionate number of cases to optimize poolability.

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 annually 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 annually.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Degenerative Disc Disease
Device: Cervical Artificial Disc
Cervical artificial disc mechanical device
  • Experimental: 1 Level Use
    Use of the Investigational Device compared to standard of care, for treatement at 1 cervical spine level.
    Intervention: Device: Cervical Artificial Disc
  • Experimental: 2Level
    Use of the Investigational Device compared to standard of care for 2 cervical spine levels.
    Intervention: Device: Cervical Artificial Disc
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
March 2018
March 2010   (final data collection date for primary outcome measure)

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

Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00389597
LDR-001, IDE Number G050212
Yes
LDR Spine USA
LDR Spine USA
Not Provided
Principal Investigator: Ralph Rashbaum, MD Texas Back Institute
LDR Spine USA
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP