Primary Objective: To investigate the primary stability of the Prodisc-C Vivo cervical disc replacement in the intercorporal space with regard to the adjacent vertebrae in patients with cervical disc disease.Secondary Objective(s): To evaluate…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
Stability of both the upper and lower end plates of the Prodisc-C Vivo cervical
disc replacement with regard to the adjacent cervical vertebrae. Stability is
defined as the absence of micro-motion or migration. Migration is defined as
the amount of translation in mm along the x-, y-, and z-axis and rotation in
degrees around the x-, y-, and z-axis. As the accuracy is only acceptable for
the translational component of migration, this is will be the main focus in
this study. Migration will be measured using model-based radiostereometric
analysis (MB-RSA). At 6 weeks, double RSA-measurements will be performed to
assess the precision of the measurement method and to assess the level of
*migration* that is no migration.
Secondary outcome
Secondary outcomes
* Neck Disability Index (NDI)
* NRS pain (arm and neck)
* Maximal flexion and maximal extension mobility of the cervical spine using
radiographic motion in the sagittal plane was measured according to the method
described by Frobin et al.
Background summary
Anterior cervical discectomy and fusion (ACDF) has been regarded the *gold
standard* of surgical intervention in the treatment of cervical disc diseases.
However, in the last years several clinical trials in which cervical total disc
replacement (CTDR) was compared with ACDF, reported results are in favour for
CTDR 1,2. Very few complications or adverse events have been mentioned. Above
all, as CTDR aims to preserve segmental motion and with that to prevent the
incidence of adjacent segment disease (ASD)3, the results of these studies
showed that the cervical disc replacement retained this segmental motion.
Cohort studies evaluating the long-term performance of different types of
cervical disc prostheses report maintenance of clinical motion and function
outcomes1,4,5 . However, due to study limitations concern still exists for
long-term heterotopic ossification at the index level, spontaneous fusion, and
failure to maintain motion and function.
The Prodisc-C Vivo is a 3rd generation (after Prodisc C and Prodisc C nova)
CE-marked disc replacement implant for patients with disc degeneration, soft
disk lesions, or cervical HNP. So far, no adverse events have been reported.
The Prodisc-C Vivo replaces the cervical intervertebral disc to restore disc
height and to maintain cervical mobility. Because of this mobility, and because
the implant will be inserted between two cervical vertebrae without additional
instrumentation, it is necessary to investigate the stability of the implant
with regard to the adjacent cervical vertebrae. Furthermore, because the
endplates of the implant are smaller than the body of the adjacent vertebrae, a
possibility exists that the implant subsides into the vertebra below the index
level. This could be detrimental for the mobility of the cervical spine. As
the implant enables mobility of the cervical spine, early return to functioning
and activities are necessary for proper functioning of the implant. This could
be achieved safely when the implant is in a primary stable position in the
intervertebral space.
Study objective
Primary Objective:
To investigate the primary stability of the Prodisc-C Vivo cervical disc
replacement in the intercorporal space with regard to the adjacent vertebrae in
patients with cervical disc disease.
Secondary Objective(s):
To evaluate mobility, pain, and function of the cervical spine after
implantation of the Prodisc-C Vivo.
Study design
This study is a single centre, single surgeon prospective cohort study. The
primary endpoint of the study is the stability of the Prodisc-C Vivo as
measured with model based radiosteriometric analysis (MB-RSA) at 6 months
follow-up.
Intervention
All patients receive the Prodisc-C Vivo cevical disc replacement.
Study burden and risks
Patients participating in this study will not be barred by any additional risk
other than the regular risks for a cervical disc replacement. Regular risks are
migration, infection, heterotopic ossification, spontaneous fusion, risks
associated with anterior decompression. These risks will be recorded.
The dose of the RSA measurement is reasonably low. The patients will visit the
clinic at regular follow-up moments. The questionnaires of the cervical spine
will take a bit more time but do not bring any extra burden. The risks
associated with participation can be considered negligible and the burden can
be considered minimal.
Hengstdal 3
Ubbergen (bij Nijmegen) 6574 NA
NL
Hengstdal 3
Ubbergen (bij Nijmegen) 6574 NA
NL
Listed location countries
Age
Inclusion criteria
* Single level C3-7 radiculopathy due to herniated disc, degenerative disc disease or spondylosis (confirmed by MRI)
* Preserved motion at symptomatic level (confirmed by flexion/extension X-rays)
* Failure of conservative treatment for at least 6 weeks
* Age > 21 years
* Written informed consent
Exclusion criteria
* Cervical deformity (kyphosis or lordosis or congenital)
* Loss of lordosis
* Multilevel spondylosis
* Disc height less than 50%
* Cervical trauma and instability
* Facet arthritis
* Infections
* Previous surgery at index level
* Osteoporosis
* Pregnancy (or plans to become pregnant during the study)
* BMI > 30
* Metastases
Design
Recruitment
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 |
|---|---|
| CCMO | NL46526.048.13 |