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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389597
• Other study ID #: LDR-001
• Status: Completed
• Phase: N/A
• First received: October 18, 2006
• Last updated: November 7, 2017
• Start date: April 2006
• Est. completion date: November 2015

Study information

• Verified date: November 2017
• Source: LDR Spine USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: November 2015
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Cervical Artificial Disc
Cervical artificial disc mechanical device

Locations

Country	Name	City	State
United States	Austin Brain and Spine	Austin	Texas
United States	GBMC Healthcare	Baltimore	Maryland
United States	Simmons Orthopaedics and Spine Associates	Buffalo	New York
United States	The Cleveland Clinic	Cleveland	Ohio
United States	University Neurologic Systems	Detroit	Michigan
United States	Southern California Institute of Neurological Surgery	Escondido	California
United States	Orthopaedics North East	Fort Wayne	Indiana
United States	Panorama Orthopedics and Spine Care	Golden	Colorado
United States	Foundation Surgical Hospital	Houston	Texas
United States	Massoudi & Jackson Neurosurgical Association	Laguna Hills	California
United States	Memorial Orthopaedic Surgical Group	Long Beach	California
United States	Orthopedic Spine Care of Long Island	Melville	New York
United States	West Texas Spine	Odessa	Texas
United States	Southeastern Clinical Research	Orlando	Florida
United States	Texas Back Institute-West	Phoenix	Arizona
United States	Texas Back Institute	Plano	Texas
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	University of California- Davis Medical Center	Sacramento	California
United States	St. Mary's of Saginaw Field Neurosciences Institute	Saginaw	Michigan
United States	Spine Institute at St. John's Health Center	Santa Monica	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Stanford University	Stanford	California
United States	Oklahoma Spine & Brain Institute	Tulsa	Oklahoma
United States	Texas Spine and Joint Hospital	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LDR Spine USA

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 sympto — View Citation

Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum R, Stokes J. Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior disc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Definition of Study Success	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

External Links

•   FDA Approval 1 Level
•   FDA Approval 2 Level