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: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
Device: Cervical Artificial Disc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Resource links provided by NLM:


Further study details as provided by LDR Spine USA:

Primary Outcome Measures:
  • Composite Definition of Study Success [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

    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


Enrollment: 599
Study Start Date: April 2006
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Level
Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level
Device: Cervical Artificial Disc
Cervical artificial disc mechanical device
Experimental: 2 Level
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
Device: Cervical Artificial Disc
Cervical artificial disc mechanical device

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389597

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

Additional Information:
Publications:
Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT00389597     History of Changes
Other Study ID Numbers: LDR-001
Study First Received: October 18, 2006
Results First Received: January 3, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by LDR Spine USA:
degenerative disc disease
cervical arthroplasty
Mobi C
multilevel
anterior cervical discectomy and fusion

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014