Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study

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.

Primary:

• Composite definition of Study Success 2 Years Yes

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

Lead Sponsor: LDR Spine USA

Texas Back Institute-West

Phoenix Arizona 85015 United States

Spine Institute at St. John's Health Center

Santa Monica California 90404 United States

University of California- Davis Medical Center

Sacramento California 95817 United States

Eisenhower Medical Center

Rancho Mirage California 92270 United States

Massoudi & Jackson Neurosurgical Association

Laguna Hills California 92653 United States

Stanford University

Stanford California 94305 United States

Southern California Institute of Neurological Surgery

Escondido California 92122 United States

Memorial Orthopaedic Surgical Group

Long Beach California 90806 United States

Panorama Orthopedics and Spine Care

Golden Colorado 80401 United States

Southeastern Clinical Research

Orlando Florida 32804 United States

Orthopaedics North East

Fort Wayne Indiana 46825 United States

Spine Institute of Louisiana

Shreveport Louisiana 71101 United States

GBMC Healthcare

Baltimore Maryland 21204 United States

University Neurologic Systems

Detroit Michigan 48201 United States

St. Mary's of Saginaw Field Neurosciences Institute

Saginaw Michigan 48604 United States

Orthopedic Spine Care of Long Island

Melville New York 11747 United States

Simmons Orthopaedics and Spine Associates

Buffalo New York 14201 United States

The Cleveland Clinic

Cleveland Ohio 44195 United States

Oklahoma Spine & Brain Institute

Tulsa Oklahoma 74132 United States

Austin Brain and Spine

Austin Texas 78701 United States

Texas Spine and Joint Hospital

Tyler Texas 75701 United States

Texas Back Institute

Plano Texas 75093 United States

West Texas Spine

Odessa Texas 79761 United States

Foundation Surgical Hospital

Houston Texas 77401 United States

Overall Clinical Trial Officials and Contacts

Ralph Rashbaum, MD Principal Investigator Texas Back Institute  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00389597

Study ID Number: LDR-001

ClinicalTrials.gov Identifier: NCT00389597

Health Authority: United States: Food and Drug Administration