Cervical Disc DiseaseDCINCT04627454
Dynamic Cervical Implant in Treatment of Cervical Disc Disease
A study testing Discectomy and insertion of dynamic cervical implant in cervical disc herniation in people with Cervical Disc Disease and Cervical Disc Herniation, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration
- What is being tested?
- Discectomy and insertion of dynamic cervical implant in cervical disc herniation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with single level cervical disc herniation ( C3 - C7 ).
- Patients with cervical canal stenosis.
- Patients with degenerative disc disease.
- Patient with cervical disc disease not responding to medical treatment.
- Age of the patient: any age.
- Patients fit for surgery.
Who cannot join
- Patients with multilevel cervical disc herniation.
- Patients with segmental instability.
- Patients with previous cervical spine surgery.
- Patients with cervical kyphosis, active infection or known allergy to titanium.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation the Safety and Effectiveness of Dynamic Cervical Implants (DCI) in Treatment of Single Level Cervical Disc Disease
- 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.
Read the detailed 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.
- Being tested
- Discectomy and insertion of dynamic cervical implant in cervical disc herniation
- Keywords
- Dynamic cervical implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discectomy and insertion of dynamic cervical implant in cervical disc herniationProcedure or surgery
The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation
| Study group | Role | What they receive |
|---|---|---|
| dynamic cervical implant | Experimental | dynamic cervical implant in treatment of cervical disc disease Receives: Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation |
| discectomy | Experimental | insertion of dynamic cervical implant post cervical discectomy single level Receives: Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of preoperative neck and radicular pain
Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.
Measured: Two days post operative
Evaluation the motor power
Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start25 Nov 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahd Abdel Sabour Ahmed Mohammed, Assiut University
- Investigators
- Abdel Hai Moussa Abdel Latif, prof., Study director, Assiut university hospital, neurosurgery departmentAhmed Elsayed Abo Kresha, prof., Study director, Assiut university hospital, neurosurgery departmentMohammed Elsayed Mahmoud, Prof., Study director, Assiut university hospital, neurosurgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627454
- Sponsor's protocol ID
- DCI in cervical disc disease
- Acronym
- DCI
- Status last verified
- Nov 2020
- First submitted
- 1 Sep 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Safety and Effectiveness of Dynamic Cervical Implants (DCI) in Treatment of Single Level Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT04627454
- Acronym / sponsor ID
- DCI / DCI in cervical disc disease
- Keywords
- Dynamic cervical implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic cervical implant | Experimental | Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniationdynamic cervical implant in treatment of cervical disc disease |
| discectomy | Experimental | Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniationinsertion of dynamic cervical implant post cervical discectomy single level |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with single level cervical disc herniation ( C3 - C7 ).
- Patients with cervical canal stenosis.
- Patients with degenerative disc disease.
- Patient with cervical disc disease not responding to medical treatment.
- Age of the patient: any age.
Key exclusion criteria (4 listed)
- Patients with multilevel cervical disc herniation.
- Patients with segmental instability.
- Patients with previous cervical spine surgery.
- Patients with cervical kyphosis, active infection or known allergy to titanium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discectomy and insertion of dynamic cervical implant in cervical disc herniationThe surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation | Procedure or surgery | discectomy, dynamic cervical implant |
Primary outcome
Change of preoperative neck and radicular pain
Time frame: Two days post operative
Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.
Evaluation the motor power
Time frame: Three months
Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdel Hai Moussa Abdel Latif, prof. study director
Assiut university hospital, neurosurgery department
Ahmed Elsayed Abo Kresha, prof. study director
Assiut university hospital, neurosurgery department
Mohammed Elsayed Mahmoud, Prof. study director
Assiut university hospital, neurosurgery department
Questions about this trial
What is this clinical trial studying?
A study testing Discectomy and insertion of dynamic cervical implant in cervical disc herniation in people with Cervical Disc Disease and Cervical Disc Herniation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahd Abdel Sabour Ahmed Mohammed, Rdr (00201029522851, dfahd81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of preoperative neck and radicular pain (time frame: Two days post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.