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Comparison between Dynamic Cervical Implant as a recently introduced technique in our department and the conventional Anterior Cervical Discectomy and Fusion in management of single-level cervical disc prolapse.
Anterior cervical discectomy and fusion (ACDF) is considered to be a highly successful surgical technique for cervical spondylosis associated with brachialgia and/or myelopathy. Non-union accounts for more than two-thirds of failures in ACDF surgeries and iliac bone graft morbidity is also reported in about one-third of multilevel fusion operations. There are many types of cages used to avoid the complications associated with iliac bone grafting.These problems include persistent donor-site pain, infection, hematoma formation, iliac crest fracture, and neuralgia parasthetica.
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
I.
• Improve the outcome of these patients and decease rate of recurrence and complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Cervical Implant | Experimental |
| |
| Anterior Cervical Discectomt and Fusion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Cervical Implant | Procedure | Cervical discectomy through anterior approach with replacement of disc by dynamic implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) of neck pain | Subjective Neck pain intensity on scale of 1-10 | six months |
| Visual Analogue Scale (VAS) of brachialgia | Subjective brachialgia intensity on scale of 1-10 | six months |
| Intervertebral Hight | The distance from the midpoint of the upper endplate of the upper vertebral body to the midpoint of the lower endplate of the lower vertebral body | six months |
| Range of motion | range of motion of affected level using Cobb's angle. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | intraoperative blood loss | immediate post operative |
| Hospital Stay | post operative hospital stay | up to one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hazem A Othman, MSc | Contact | 01060324743 | 002 | dr.hazem.othman1990@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed E Abokresha, Professor | Assiut University | Study Chair |
| Shady A Hassaan, MD | Assiut University | Study Director |
| Hazem A Othman, MSc |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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| Anterior Cervical Discectomt and Fusion | Procedure | Cervical discectomy through anterior approach with putting of cervical cage. |
|
| Assiut University |
| Principal Investigator |