The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial CervicalDisc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index(NDI) and neurological function…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
The primary endpoint is patient success as determined by clinical outcome
measures.
1)Clinical Success requires a minimum of 15-point improvement in NDI,
2) no new clinically significant permanent abnormalities in neurological
function (i.e., motor strength, nerve
root tension signs, sensory and reflex signs),
3) no subsequent secondary surgical interventions at the index level, and no
device-related serious adverse
events (SAE) from baseline through 24-months
Secondary outcome
Secundary study parameters/outcome of the study (if applicable):
Secondary endpoints:
• The change in pain relief assessed via Visual Analogue Scale (VAS) from
pre-treatment for DISCOVER will be
measured prior to discharge post op, 2 weeks, 3, 6, 12 and 24 months post op
and compared
with ACDF
• The change in Quality of Life assessed by SF-36 from pre-treatment for
DISCOVER will be measured at 12 and
24 months post op and compared with ACDF
• The change in function assessed by Neck Disability Index from pre-treatment
for DISCOVER will be
measured at 2 weeks, 3, 6, 12 and 24 months post op and compared with ACDF
• The change in Neurological function assessed by motor strength, nerve root
tension signs, sensory and
reflex signs from pre-treatment for DISOVER will be measured prior to
discharge, 2 weeks, 3, 6, 12 and 24 months post op and compared with ACDF
• The work status of the subject will be assessed from pre-treatment for
DISCOVER and measured at 2 weeks,
3, 6, 12 and 24 months post op and compared with ACDF
• The effect on sagittal angulation, measured by Radiographic Grade for
DISCOVER will be measured at pretreatment,
prior to discharge post op, 2 weeks, 3, 6, 12 and 24 months post op and
compared with ACDF
• The effect on adjacent level degeneration measured by Radiographic Grade for
DISCOVER will be measured
at pre-treatment and 24 months and compared with ACDF
• The effect on maintenance of disc height measured by Radiographic Grade for
DISCOVER will be measured
at pre-treatment, prior to discharge post op, 2 weeks, 3, 6, 12 and 24 months
and compared with ACDF
• The effect on foraminal height measured by Radiographic Grade for DISCOVER
will be measured at pretreatment,
12 and 24 months and compared with ACDF
• The effect on Cervical Range of Movement (CROM) measured by Radiographic
Grade for DISCOVER will be
measured at pre-treatment, 3, 6, 12 and 24 months and compared with ACDF
• The safety of the DISCOVER Artificial Cervical Disc by documenting the
incidence of device-related serious
adverse events and monitoring neurological function as measured by neurological
examination and compared with ACDF
• Implant survival for surgical revision at the level of intervention assessed
throughout 60 months of followup.
Background summary
Anterior cervical discectomy and fusion (ACDF) was initially described by
Robinson and Smith, and then by
Cloward in the late 1950's 1, 2. The ACDF procedure has gained increasing
popularity amongst neurosurgeons
and orthopaedic spine surgeons and is an established procedure for the surgical
treatment of cervical disc
herniation and spondylosis3. The ACDF procedure has a history of success with
regard to fusion, with success
rates at or above 90% 4-8 Even though ACDF has been the treatment of choice for
physicians treating
patients with cervical degenerative disc disease (DDD), there has been
increasing concern at the possible
acceleration of adjacent level degeneration, and loss of motion.
Based on reported short-term outcomes, maintaining or restoring motion at a
diseased cervical joint appears
to be a viable option in terms of preventing or limiting adjacent level disc
disease, and relieving pain and
radicular symptoms of those affected with this debilitating disease.
Study objective
The primary objective of this investigation is to evaluate the performance of
the DISCOVER Artificial Cervical
Disc in the treatment of cervical disc disease by measuring the function
assessed via Neck Disability Index
(NDI) and neurological function when compared to Anterior Cervical Discectomy
and Fusion (ACDF).
Study design
A multi-centre, prospective, randomised, post marketing surveillance study.
Subjects will either receive allograft bone with an anterior cervical plate and
allograft (control group) or an artificial cervical disc (investigational
group).
Intervention
Subjects with cervical disease are currently treated with Anterior Cervical
Decompression and Fusion (ACDF)
or cervical disc replacement. Cervical spinal fusion is a surgery that joins
selected bones in the cervical spine
(neck). There are different methods of performing a cervical spinal fusion. The
method for this research study
will use allograft bone (bone donated from another patient) that is placed in
the space where the disc was, together with a plate fixed to the bone above and
below the removed disc to join together the affected bones in the neck.
SLIM-Loc Anterior Cervical Plate is the name of the plate that is being used in
the study.
The newer treatment that subjects may get by taking part in this research study
is cervical arthroplasty using
the DISCOVERTM artificial cervical disc, this is a disc replacement treatment,
which means the surgeon will
remove the affected disc and insert the artificial disc. Both operations will
be performed through an incision on the front of the neck.
Study burden and risks
Any surgical procedure poses a potential risk and the procedures undertaken as
part of this clinical
investigation are no exception. There are known risks associated with the
method of anaesthesia (general,
epidural, local). In addition to these there are risks associated with a
surgical procedure that involves a
device. A complication may require revision surgery. Very rarely a complication
may prove fatal. Risks that are associated with the use of the Artificial
Cervical Disc are expected to be similar to risks associated with ACDF. An
extensive literature review was performed on the use of ACDF in subjects with
DDD.
Potential risks include, but are not limited to, procedure-related
complications that are intrinsic to the anterior
cervical surgical approach (See section E9 on this form).
Computerweg 14
Amersfoort 3821AB
NL
Computerweg 14
Amersfoort 3821AB
NL
Listed location countries
Age
Inclusion criteria
Key Inclusion Criteria:;- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as
(a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or
(b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits
Exclusion criteria
Key Exclusion Criteria:;- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- History of alcohol and/or drug abuse
- Any known allergy to a metal alloy or polyethylene
- Morbid obesity
- Any significant general illness (e.g., metastatic cancer, HIV)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00432159 |
| CCMO | NL27720.008.09 |