Clinical trial NCT05101967: Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion
Official title: Dynamic Cervical Implant (DCI) vs. Anterior Cervical Discectomy and Fusion (ACDF) in Treatment of Single-level Cervical Disc Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Disc Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

* 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

Eligibility criteria: Inclusion Criteria:

1. Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
2. Age of the patient is between 18- 60 years old of both sex.
3. Patients are fit for surgery..

Exclusion Criteria:

1. Patients with multilevel cervical disc prolapse.
2. Patients with recurrent disc prolapse.
3. Spinal deformity
4. Spinal instability.
5. Patients who are unfit for surgery

Primary outcomes:
measure: Visual Analogue Scale (VAS) of neck pain
timeFrame: six months
measure: Visual Analogue Scale (VAS) of brachialgia
timeFrame: six months
measure: Intervertebral Hight
timeFrame: six months
measure: Range of motion
timeFrame: six months
Secondary outcomes:
measure: Blood Loss
timeFrame: immediate post operative
measure: Hospital Stay
timeFrame: up to one week
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed E Abokresha, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Shady A Hassaan, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hazem A Othman, MSc
role: PRINCIPAL_INVESTIGATOR
References: