Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
LDR Spine USA

Tracking Information
First Submitted Date  ICMJE October 18, 2006
First Posted Date  ICMJE October 19, 2006
Results First Submitted Date  ICMJE January 3, 2014
Results First Posted Date  ICMJE May 1, 2014
Last Update Posted Date December 11, 2017
Study Start Date  ICMJE April 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE Device: Cervical Artificial Disc
Cervical artificial disc mechanical device
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2014)
599
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389597
Other Study ID Numbers  ICMJE LDR-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LDR Spine USA
Study Sponsor  ICMJE LDR Spine USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ralph Rashbaum, MD Texas Back Institute
PRS Account LDR Spine USA
Verification Date November 2017

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