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xx Mobi-CŪ Cervical Artificial Disc Replacement Clini
« Thread started on: Feb 12th, 2007, 10:11am »

Mobi-CŪ Cervical Artificial Disc Replacement Clinical Trial
(Sponsored clinical trial listing)

http://www.spine-health.com/research/trials/mobi/mobi01.html

Mobi-CŪ is a total disc replacement
The Mobi-CŪ is a total disc replacement that is implanted in place of the damaged adjacent discs and can be used by your surgeon to replace up to two damaged discs in the neck. The Mobi-C cervical disc prosthesis is designed to provide an additional therapeutic option to maintain motion segment position and spacing while preserving flexibility in the affected cervical vertebral level.

Mobi-CŪ cervical artificial disc replacement—study objectives
The primary objective of the study is to establish the safety and effectiveness of the Mobi-C prosthesis investigational device as compared to the control (ACDF) with anterior cervical plate (control group) in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels between C3 and C7 who are unresponsive to non-operative conservative treatment.

Mobi-CŪ cervical artificial disc replacement—study overview
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).

A maximum of 20 centers will participate in the study. The research study will involve approximately 600 patients, randomized in a 2 to 1 ratio, (two Mobi-C patients to every one ACDF patient). 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. The total study duration is estimated to be five years.

There should be no additional costs to the patient for particpation in the study, except for required deductibles and copays associated with insurance. Patients who recieve the Mobi-C as part of this study will have all doctor, hospital, prosthesis, and surgery-related costs that are not coverd by insurance paid by the sponsor of the study.

The Mobi-C has been implanted in over 1400 patients outside the United States since 2004.

Mobi-CŪ Study sponsor

LDR Spine, Austin, TX
www.ldrspine.com

Mobi-CŪ Study status

Recruiting

Inclusion Criteria for the Mobi-CŪ cervical artificial disc study

Pre-screening Criteria (Please visit www.secondgenerationdisc.com for a more detailed list)

To be eligible for the study patients must:

Be between 18 and 69 years old
Have at least one of the following symptoms: Neck and/or arm pain; decreased muscle strength, abnormal sensation or reflexes related to a cervical spine condition
Exclusion Criteria for the Mobi-CŪ cervical artificial disc study

Pre-screening Criteria (please visit www.secondgenerationdisc.com for a more detailed list)

To be eligible for the study patients cannot meet any of the following:

Prior cervical spine fusion surgery of any spine segment
Pregnant or nursing at time of enrollment, or with plans to become pregnant within the next three years
Daily, high-dose oral and/or inhaled steroids use, defined as either oral steroids use of at least 5 mg/day or inhaled corticosteroids at least twice per day
Current or recent history of substance abuse requiring intervention
Morbid obesity
Smoking more than one pack of cigarettes per day
Participating Sites and Contact Information for the Mobi-CŪ study

Please visit www.secondgenerationdisc.com for a complete list of participating sites and contact information.

Caution: The cervical Mobi-CŪ artificial disc is an Investigational Device and is limited to investigational use in the United States.

Return to Clinical Trials Health Hub
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