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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Prolapse

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    October 20, 2021
    Last Updated
    October 29, 2021
    Sponsor
    Assiut University
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    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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