Introduction
Pain associated with spinal disease represents one
of the most common reasons for doctor visits in the United
States. It is estimated that 80% of the U.S. population
will experience at least one episode of significant pain
as a result of disc herniations or other spinal problems
in their lifetime.
What causes the pain? And how is this pain treated? The
answers to these questions are dependent upon many factors
and can only be answered completely by a physician specializing
in the treatment of spinal disorders. For the purposes
of this clinical study, specific focus is directed to
pain resulting from a disc herniation in the upper area
(your neck) of your spine.
 This area of your spinal column
is known as the cervical spine. It is comprised of
seven vertebrae (bones) which are connected to one
another by a shock absorbing and flexible disc. The
spinal disc contains a fibrous outer layer (the annulus)
surrounding a soft, jelly like core (the nucleus).
Together, the vertebrae and spinal discs form joints,
allowing you to rotate and bend your neck. Sometimes,
because of the demands placed upon the disc, it can
wear or herniate over
time. This disease process is part of a family of disorders
called Degenerative Disc Disease (DDD).
When a disc
herniates, the resulting material may press against
the spinal cord or its branching nerve roots. Signals
from compression of the spinal cord or nerve roots
are often felt as pain, weakness or numbness along
a path as opposed to
just at a spot. For example, a disc
herniation in the neck can be felt in the shoulder,
down the arm, and even into the hand.
Neck and arm pain/weakness caused by a disc herniation
is usually given conservative treatment for as long
as possible. When such treatment no longer provides
relief, the primary solution is removal of the affected
discs and fusion or “joining” of the vertebral
segments. It is estimated that 125,000 people
in the U.S. undergo cervical (upper spine) fusion procedures
each year. Spinal fusion is a highly successful
operation and usually relieves pain and other symptoms,
but does result in loss of motion in the fused joint.
As
a possible alternative to spinal fusion, the PCM cervical
disc replacement system has been developed. The
intent of the PCM® is to provide the relief of
pain and symptoms, with the possibility of retaining
motion at the treated joint. The device is constructed
of two cobalt chromium alloy endplates surrounding
a special grade plastic core. The top metal endplate
is designed to “glide” over, around, and
across the core, potentially helping to restore or
maintain motion after removal of the diseased disc
and bone.
Study objectives
The objective of this clinical
study is to evaluate the safety and effectiveness of
the Porous Coated Motion (PCM®) disc for the treatment of disc herniation(s)
or other degenerative disc disease (DDD) in the upper
(cervical) spine. The study hopes to provide
some answers as to how the PCM® artificial cervical
disc replacement compares to spinal fusion in the treatment
of this disease.
Study overview
This is an FDA controlled prospective,
randomized clinical trial. Several hundred patients will
be enrolled at up to 20 sites around the country. Study
participants will be patients who suffer from DDD (commonly
a disc herniation) and the resulting neck, arm and/or
shoulder pain/weakness (neurological symptoms) at one
level between C3 to T1.
All patients who meet the inclusion/exclusion criteria
and who elect to participate and who sign the Informed
Consent document will be included in the trial. Once
enrolled, patients will be randomly assigned to the
treatment group (PCM®) or to the control group
(anterior cervical fusion).
Following treatment, patients will visit their treating
physician on a scheduled basis to report on their outcome
relating to relief of pain, functional status, return
to work, etc. Results from these visits will
be used to evaluate the safety and efficacy of the
procedure.
Study sponsor
Cervitech, Inc.
www.cervitech.com
Status
Recruiting
Inclusion criteria
(Summary)
- Age 18-65 years;
- Diagnosis of radiculopathy or myelopathy of the
cervical spine;
- Symptomatic at only one level from C3-C4 to C7-T1;
- Unresponsive to non-operative treatment for six
weeks, or has the presence of progressive symptoms
or signs of nerve root/spinal cord compression
in the face of conservative treatment;
- Appropriate for treatment using an anterior surgical
approach
Exclusion criteria
(Summary)
- Infection at the site of surgery;
- History of, or anticipated treatment for, active
systemic infection including HIV infection or Hepatitis
C;
- Previous trauma to the C3-T1 levels resulting
in significant bony or disco-ligamentous cervical
spine injury;
- Localized neck pain in the absence of other “radicular” (shooting
pain or weakness down to the shoulder and/or arm)
symptoms;
- Osteoporosis;
- Severe diabetes mellitus requiring daily insulin
management;
- Tumor as the source of symptoms;
- Pregnancy
Participating sites and contact information
Please visit www.cervitech.com and
click on “For Patients” to see participating
sites/contacts.
Caution -- Investigational Device, Limited by United
States Law to Investigational Use.
Introduction
Pain associated with spinal disease represents one
of the most common reasons for doctor visits in the United
States. It is estimated that 80% of the U.S. population
will experience at least one episode of significant pain
as a result of disc herniations or other spinal problems
in their lifetime.
What causes the pain? And how is this pain treated? The
answers to these questions are dependent upon many factors
and can only be answered completely by a physician specializing
in the treatment of spinal disorders. For the purposes
of this clinical study, specific focus is directed to
pain resulting from a disc herniation in the upper area
(your neck) of your spine.
This area of your spinal column
is known as the cervical spine. It is comprised of
seven vertebrae (bones) which are connected to one
another by a shock absorbing and flexible disc. The
spinal disc contains a fibrous outer layer (the annulus)
surrounding a soft, jelly like core (the nucleus).
Together, the vertebrae and spinal discs form joints,
allowing you to rotate and bend your neck. Sometimes,
because of the demands placed upon the disc, it can
wear or herniate over
time. This disease process is part of a family of disorders
called Degenerative Disc Disease (DDD).
When a disc
herniates, the resulting material may press against
the spinal cord or its branching nerve roots. Signals
from compression of the spinal cord or nerve roots
are often felt as pain, weakness or numbness along
a path as opposed to
just at a spot. For example, a disc
herniation in the neck can be felt in the shoulder,
down the arm, and even into the hand.
Neck and arm pain/weakness caused by a disc herniation
is usually given conservative treatment for as long
as possible. When such treatment no longer provides
relief, the primary solution is removal of the affected
discs and fusion or “joining” of the vertebral
segments. It is estimated that 125,000 people
in the U.S. undergo cervical (upper spine) fusion procedures
each year. Spinal fusion is a highly successful
operation and usually relieves pain and other symptoms,
but does result in loss of motion in the fused joint.
As
a possible alternative to spinal fusion, the PCM cervical
disc replacement system has been developed. The
intent of the PCM® is to provide the relief of
pain and symptoms, with the possibility of retaining
motion at the treated joint. The device is constructed
of two cobalt chromium alloy endplates surrounding
a special grade plastic core. The top metal endplate
is designed to “glide” over, around, and
across the core, potentially helping to restore or
maintain motion after removal of the diseased disc
and bone.
Study objectives
The objective of this clinical
study is to evaluate the safety and effectiveness of
the Porous Coated Motion (PCM®) disc for the treatment of disc herniation(s)
or other degenerative disc disease (DDD) in the upper
(cervical) spine. The study hopes to provide
some answers as to how the PCM® artificial cervical
disc replacement compares to spinal fusion in the treatment
of this disease.
Study overview
This is an FDA controlled prospective,
randomized clinical trial. Several hundred patients will
be enrolled at up to 20 sites around the country. Study
participants will be patients who suffer from DDD (commonly
a disc herniation) and the resulting neck, arm and/or
shoulder pain/weakness (neurological symptoms) at one
level between C3 to T1.
All patients who meet the inclusion/exclusion criteria
and who elect to participate and who sign the Informed
Consent document will be included in the trial. Once
enrolled, patients will be randomly assigned to the
treatment group (PCM®) or to the control group
(anterior cervical fusion).
Following treatment, patients will visit their treating
physician on a scheduled basis to report on their outcome
relating to relief of pain, functional status, return
to work, etc. Results from these visits will
be used to evaluate the safety and efficacy of the
procedure.
Study sponsor
Cervitech, Inc.
www.cervitech.com
Status
Recruiting
Inclusion criteria
(Summary)
- Age 18-65 years;
- Diagnosis of radiculopathy or myelopathy of the
cervical spine;
- Symptomatic at only one level from C3-C4 to C7-T1;
- Unresponsive to non-operative treatment for six
weeks, or has the presence of progressive symptoms
or signs of nerve root/spinal cord compression
in the face of conservative treatment;
- Appropriate for treatment using an anterior surgical
approach
Exclusion criteria
(Summary)
- Infection at the site of surgery;
- History of, or anticipated treatment for, active
systemic infection including HIV infection or Hepatitis
C;
- Previous trauma to the C3-T1 levels resulting
in significant bony or disco-ligamentous cervical
spine injury;
- Localized neck pain in the absence of other “radicular” (shooting
pain or weakness down to the shoulder and/or arm)
symptoms;
- Osteoporosis;
- Severe diabetes mellitus requiring daily insulin
management;
- Tumor as the source of symptoms;
- Pregnancy
Participating sites and contact information
Please visit www.cervitech.com and
click on “For Patients” to see participating
sites/contacts.
Caution -- Investigational Device, Limited by United
States Law to Investigational Use.
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