The Mobi-C® 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.
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.
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-C® Study sponsor
LDR Spine, Austin, TX
Mobi-C® Study status
Recruiting
Inclusion Criteria for the Mobi-C® cervical
artificial disc study
Pre-screening Criteria (Please visit 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-C® cervical
artificial disc study
Pre-screening Criteria (please visit 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-C® study
Please visit for
a complete list of participating sites and contact
information.
Caution: The cervical Mobi-C® artificial disc
is an Investigational Device and is limited to investigational
use in the United States.
