Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion
NCT ID: NCT05101967
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-11-01
2024-05-01
Brief Summary
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Detailed Description
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However, in spite of being successful for many years, ACDF has its own complications in the form of non-union, implant failure, and adjacent level disease which occurs due to the excessive motion observed at the levels immediately above and/or below the index level. It has been proven to provide clinical stability after decompression.. However, although it achieves long-term success, ACDF is not without complications as there have been reports of pseudoarthrosis, implant failure, and adjacent level disease which occurs due to the significant amount of increased motion observed at the levels immediately above and below the fusion. However, greater compensation occurred at the inferior segments compared to the superior segments for the lower level fusions.
Dynamic cervical Implant (DCI) is a titanium implant, originally invented in 2002 by Dr. Guy Matgé, Luxembourg. It was introduced in clinical use, in 2004. The design was modified to better accommodate the normal disc anatomy. The DCI implant with its motion preservation characters is unique implant. It stabilizes the cervical spine while still offering a limited, controlled flexion and extension movements allowing the spine to dynamically perform its function. It also acts as a shock absorber, preventing accelerated degeneration in adjacent segments. Thus, the DCI implant aims at combining the advantages of the gold standard "fusion" with a motion preservation philosophy.
This study aims to
* compare the clinical and radiographic outcomes of ACDF versus DCI in patients with degenerative cervical radiculopathy and/or myelopathy operated upon at Assiut University Hospital.
* Give the effective treatment, pain control and can detect the best method could be used in such cases.
I.
• Improve the outcome of these patients and decease rate of recurrence and complications
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dynamic Cervical Implant
Dynamic Cervical Implant
Cervical discectomy through anterior approach with replacement of disc by dynamic implant
Anterior Cervical Discectomt and Fusion
Anterior Cervical Discectomt and Fusion
Cervical discectomy through anterior approach with putting of cervical cage.
Interventions
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Dynamic Cervical Implant
Cervical discectomy through anterior approach with replacement of disc by dynamic implant
Anterior Cervical Discectomt and Fusion
Cervical discectomy through anterior approach with putting of cervical cage.
Eligibility Criteria
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Inclusion Criteria
2. Age of the patient is between 18- 60 years old of both sex.
3. Patients are fit for surgery..
Exclusion Criteria
2. Patients with recurrent disc prolapse.
3. Spinal deformity
4. Spinal instability.
5. Patients who are unfit for surgery
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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H A Othman
Registrar
Principal Investigators
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Ahmed E Abokresha, Professor
Role: STUDY_CHAIR
Assiut University
Shady A Hassaan, MD
Role: STUDY_DIRECTOR
Assiut University
Hazem A Othman, MSc
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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Other Identifiers
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DCI vs. ACDF
Identifier Type: -
Identifier Source: org_study_id