Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04627454 |
| Other study ID # |
DCI in cervical disc disease |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2020 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
Assiut University |
| Contact |
Fahd Abdel Sabour Ahmed Mohammed, Rdr |
| Phone |
00201029522851 |
| Email |
dfahd81[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
- Evaluation of outcome of DCI in treatment of cervical disc disease to patients admitted
to neurosurgery department, Asyut University Hospitals.
- Give the effective treatment, pain control and can detect the best method could be used.
- Improve the outcome of these patients and decease rate of recurrence and complications.
Description:
Anterior cervical decompression and fusion (ACDF) is the traditional method for treating
degenerative cervical disc disease, providing satisfactory results in a high proportion of
patients. However, stabilization of the treated segment may result in loss of mobility as a
functional spinal unit and acceleration of degeneration of the adjacent disc. Re operations
may be required to treat complications of fusion, such as recurrent radicular symptoms,
non-union, graft collapse, or expulsion. Many previous studies have shown that loss of motion
at the fused level is compensated by increased motion at adjacent segments after ACDF, which
induces a high rate of degenerative change adjacent to the fused segment. Cervical non-fusion
techniques have increasingly been accepted and applied by spine surgeons. As a main component
of cervical non-fusion techniques, artificial cervical disc replacement provides good ROM of
the cervical spine. Dynamic cervical stabilization with the DCI is a novel treatment approach
for cervical disc disease that was initially conceived as a method to combine the potential
advantages of fusion and total disc replacement. The first DCI was designed by Matgé in 2002
for treating cervical spondylosis. Paradigm spine introduced the second generation DCIs in
2005. A U-shaped appearance and axial elasticity are two the most significant
characteristics. A prospective study by Matgé et al. in 2009 showed that the clinical
efficacy was satisfactory after DCI replacement in 102 cases of cervical spondylosis and
during a 1-year follow-up; there was neither device migration nor subsidence. The basic
concept of the inter-body implant is to maintain a distraction-compression mechanism and so
avoid possible collapse of the disc height. This is achieved using the special titanium-alloy
DCI, which is bio compatible, available in various sizes, and provided with different foot
prints. The U-shaped body provides support and has tooth-like serrations that resist
expulsion or retropulsion of the implant when placed into the inter-vertebral space. With the
end-plate left intact, osteogenesis and bone fusion are inhibited and no further hetero-topic
fusions are supposed to occur. The initial clinical and radio graphic results with the DCI
appear promising as an alternative to TDR and ACDF in the treatment of cervical disc disease.
It affords maximal neurological improvement, along with maintenance of excellent clinical
outcomes. The potential bio-mechanical advantages of DCI include the ability to maintain
device-level motion and minimize the development of adjacent-segment disease, while
protecting the facet joints from excessive stresses noted with other motion-preserving
devices during lateral bending, axial rotation, and extension. The surgical technique
included the use of a conventional anterior cervical approach and discectomy. As reported,
disc replacement with DCI is a new strategy, in between ACDF & ADR. It is an intermediate
solution in the spectrum of management strategies of cervical disc diseases. Immediate
dynamic stability with good clinical response and no implant-related morbidity or
complications are the main advantages of this implant.
