Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion
Primary Purpose
Cervical Disc Prolapse
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Cervical Implant
Anterior Cervical Discectomt and Fusion
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Prolapse
Eligibility Criteria
Inclusion Criteria:
- Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
- Age of the patient is between 18- 60 years old of both sex.
- Patients are fit for surgery..
Exclusion Criteria:
- Patients with multilevel cervical disc prolapse.
- Patients with recurrent disc prolapse.
- Spinal deformity
- Spinal instability.
- Patients who are unfit for surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dynamic Cervical Implant
Anterior Cervical Discectomt and Fusion
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) of neck pain
Subjective Neck pain intensity on scale of 1-10
Visual Analogue Scale (VAS) of brachialgia
Subjective brachialgia intensity on scale of 1-10
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
Range of motion
range of motion of affected level using Cobb's angle.
Secondary Outcome Measures
Blood Loss
intraoperative blood loss
Hospital Stay
post operative hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05101967
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Cervical Implant
Arm Type
Experimental
Arm Title
Anterior Cervical Discectomt and Fusion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Dynamic Cervical Implant
Intervention Description
Cervical discectomy through anterior approach with replacement of disc by dynamic implant
Intervention Type
Procedure
Intervention Name(s)
Anterior Cervical Discectomt and Fusion
Intervention Description
Cervical discectomy through anterior approach with putting of cervical cage.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) of neck pain
Description
Subjective Neck pain intensity on scale of 1-10
Time Frame
six months
Title
Visual Analogue Scale (VAS) of brachialgia
Description
Subjective brachialgia intensity on scale of 1-10
Time Frame
six months
Title
Intervertebral Hight
Description
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
Time Frame
six months
Title
Range of motion
Description
range of motion of affected level using Cobb's angle.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Blood Loss
Description
intraoperative blood loss
Time Frame
immediate post operative
Title
Hospital Stay
Description
post operative hospital stay
Time Frame
up to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with single level cervical disc prolapse in the subaxial cervical vertebrae (C3 - C7) confirmed by MRI.
Age of the patient is between 18- 60 years old of both sex.
Patients are fit for surgery..
Exclusion Criteria:
Patients with multilevel cervical disc prolapse.
Patients with recurrent disc prolapse.
Spinal deformity
Spinal instability.
Patients who are unfit for surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazem A Othman, MSc
Phone
01060324743
Ext
002
Email
dr.hazem.othman1990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed E Abokresha, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shady A Hassaan, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hazem A Othman, MSc
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Dynamic Cervical Implant vs. Anterior Cervical Discectomy and Fusion
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