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Sponsored by: |
LDR Spine USA |
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Information provided by: | LDR Spine USA |
ClinicalTrials.gov Identifier: | NCT00389597 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE |
Estimated Enrollment: | 600 |
Study Start Date: | April 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following:
Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
Note: Not a complete listing
Exclusion Criteria:
Note: Not a complete listing
United States, Arizona | |
Texas Back Institute-West | |
Phoenix, Arizona, United States, 85015 | |
United States, California | |
Spine Institute at St. John's Health Center | |
Santa Monica, California, United States, 90404 | |
University of California- Davis Medical Center | |
Sacramento, California, United States, 95817 | |
Stanford University | |
Stanford, California, United States, 94305 | |
Massoudi & Jackson Neurosurgical Association | |
Laguna Hills, California, United States, 92653 | |
Eisenhower Medical Center | |
Rancho Mirage, California, United States, 92270 | |
Southern California Institute of Neurological Surgery | |
Escondido, California, United States, 92122 | |
Memorial Orthopaedic Surgical Group | |
Long Beach, California, United States, 90806 | |
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 | |
Orthopedic Spine Care of Long Island | |
Melville, New York, United States, 11747 | |
Simmons Orthopaedics and Spine Associates | |
Buffalo, New York, United States, 14201 | |
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 | |
Texas Spine and Joint Hospital | |
Tyler, Texas, United States, 75701 | |
Texas Back Institute | |
Plano, Texas, United States, 75093 | |
West Texas Spine | |
Odessa, Texas, United States, 79761 | |
Foundation Surgical Hospital | |
Houston, Texas, United States, 77401 |
Principal Investigator: | Ralph Rashbaum, MD | Texas Back Institute |
Responsible Party: | LDR Spine USA ( Noah Bartsch, MS, Manager of Clinical Affairs ) |
Study ID Numbers: | LDR-001, IDE Number G050212 |
Study First Received: | October 18, 2006 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00389597 |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Meloxicam Bone Diseases |