Dynamic Cervical Implant in Treatment of Cervical Disc Disease (DCI)
Primary Purpose
Cervical Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Discectomy and insertion of dynamic cervical implant in cervical disc herniation
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Disease focused on measuring Dynamic cervical implant
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dynamic cervical implant
discectomy
Arm Description
dynamic cervical implant in treatment of cervical disc disease
insertion of dynamic cervical implant post cervical discectomy single level
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04627454
Brief Title
Dynamic Cervical Implant in Treatment of Cervical Disc Disease
Acronym
DCI
Official Title
Evaluation the Safety and Effectiveness of Dynamic Cervical Implants (DCI) in Treatment of Single Level Cervical Disc Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration
Keywords
Dynamic cervical implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dynamic cervical implant
Arm Type
Experimental
Arm Description
dynamic cervical implant in treatment of cervical disc disease
Arm Title
discectomy
Arm Type
Experimental
Arm Description
insertion of dynamic cervical implant post cervical discectomy single level
Intervention Type
Procedure
Intervention Name(s)
Discectomy and insertion of dynamic cervical implant in cervical disc herniation
Intervention Description
The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation
Primary Outcome Measure Information:
Title
Change of preoperative neck and radicular pain
Description
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.
Time Frame
Two days post operative
Title
Evaluation the motor power
Description
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.
Time Frame
Three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahd Abdel Sabour Ahmed Mohammed, Rdr
Phone
00201029522851
Email
dfahd81@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdel Hai Moussa Abdel Latif, prof.
Organizational Affiliation
Assiut university hospital, neurosurgery department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Elsayed Abo Kresha, prof.
Organizational Affiliation
Assiut university hospital, neurosurgery department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammed Elsayed Mahmoud, Prof.
Organizational Affiliation
Assiut university hospital, neurosurgery department
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/15541695/
Description
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URL
https://pubmed.ncbi.nlm.nih.gov/9474724/
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URL
https://pubmed.ncbi.nlm.nih.gov/12435970/
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URL
https://pubmed.ncbi.nlm.nih.gov/19127159/
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URL
https://pubmed.ncbi.nlm.nih.gov/19262984/
Description
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URL
https://pubmed.ncbi.nlm.nih.gov/10225797/
Description
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URL
https://pubmed.ncbi.nlm.nih.gov/14748566/
Description
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URL
https://europepmc.org/article/med/12902946
Description
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URL
https://pubmed.ncbi.nlm.nih.gov/18785525/
Description
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URL
https://doi.org/10.3171/foc.2004.17.3.10
Description
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URL
https://pubmed.ncbi.nlm.nih.gov/17355018/
Description
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URL
https://thejns.org/downloadpdf/journals/j-neurosurg-spine/22/3/article-p237.pdf
Description
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URL
https://www.banglajol.info/index.php/BMRCB/article/download/12884/9251
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URL
https://pubmed.ncbi.nlm.nih.gov/17721713/
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URL
https://www.google.com/search?rlz=1C1CHBD_arEG909EG909&sxsrf=ALeKk02OsmpENAj4A5tcvZVyY4KF8Rl3eA:1599003417496&q=18.%09De+Bowes+RM,+Grant+BD,+Bagby+GW,+Butts+MK.+Cervical+vertebral+interbody+fusion+in+the+horse:+a+comparative+study+of+bovine+xenografts+and+allografts+supported+by+stainless+steel+baskets.+Am+J+Vet+Res+1984;+45:+191-9&spell=1&sa=X&ved=2ahUKEwjJ4cb1j8nrAhUO1BoKHbpSBu8QkeECKAB6BAgKECo
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Dynamic Cervical Implant in Treatment of Cervical Disc Disease
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