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

November 7, 2017 updated by: LDR Spine USA
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 Overview

Status

Completed

Intervention / 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

Enrollment (Actual)

599

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Texas Back Institute-West
    • California
      • Escondido, California, United States, 92122
        • Southern California Institute of Neurological Surgery
      • Laguna Hills, California, United States, 92653
        • Massoudi & Jackson Neurosurgical Association
      • Long Beach, California, United States, 90806
        • Memorial Orthopaedic Surgical Group
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Sacramento, California, United States, 95817
        • University of California- Davis Medical Center
      • Santa Monica, California, United States, 90404
        • Spine Institute at St. John's Health Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Golden, Colorado, United States, 80401
        • Panorama Orthopedics and Spine Care
    • Florida
      • Orlando, Florida, United States, 32804
        • Southeastern Clinical Research
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Orthopaedics North East
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • GBMC Healthcare
    • Michigan
      • Detroit, Michigan, United States, 48201
        • University Neurologic Systems
      • Saginaw, Michigan, United States, 48604
        • St. Mary's of Saginaw Field Neurosciences Institute
    • New York
      • Buffalo, New York, United States, 14201
        • Simmons Orthopaedics and Spine Associates
      • Melville, New York, United States, 11747
        • Orthopedic Spine Care of Long Island
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • Oklahoma Spine & Brain Institute
    • Texas
      • Austin, Texas, United States, 78701
        • Austin Brain and Spine
      • Houston, Texas, United States, 77401
        • Foundation Surgical Hospital
      • Odessa, Texas, United States, 79761
        • West Texas Spine
      • Plano, Texas, United States, 75093
        • Texas Back Institute
      • Tyler, Texas, United States, 75701
        • Texas Spine and Joint Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Level
Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level
Cervical artificial disc mechanical device
Experimental: 2 Level
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
Cervical artificial disc mechanical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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