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Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

Primary Purpose

Cervical Degenerative Disc Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical spine surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Degenerative Disc Disease focused on measuring Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management
  • Age older than 18 years

Exclusion Criteria:

  1. ossification of posterior longitudinal ligament
  2. facet arthritis
  3. lack of motion or instability at the level of surgery
  4. fracture
  5. infection
  6. tumors
  7. osteoprosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group (1) (ACDF)

    Group (2) (DCI)

    Arm Description

    All patients on this group will undergo Anterior Cervical Discectomy And Fusion

    All patients on this group will undergo Dynamic Cervical Implant

    Outcomes

    Primary Outcome Measures

    Radiological outcome
    MRI grading for the degree of ASD (Mario Matsumato grading)

    Secondary Outcome Measures

    Clinical outcome
    1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse
    Radiological outcome (Plain x-ray)
    1- Cervical sagittal alignment C2 to C7 (Cobb angle) 5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae.
    Radiological outcome (MSCT)
    1-implant fusion
    clinical outcome
    Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse
    radiological outcome
    2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment

    Full Information

    First Posted
    August 19, 2022
    Last Updated
    August 27, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05522010
    Brief Title
    Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
    Official Title
    Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 25, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 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

    5. Study Description

    Brief Summary
    TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)
    Detailed Description
    Anterior cervical discectomy and fusion (ACDF) is an effective and safe treatment for patients with radiculopathy and myelopathy. However, in the untreated levels adjacent to a fusion, increased motion and elevated intradiscal pressures have been reported. Some investigators have postulated that these changes may lead to an increased risk of adjacent segment degeneration (ASD). Limitations and problems with ACDF have led some investigators to explore the motion-preserving surgeries, such as cervical total disk replacement (TDR). Although TDR has been shown to reduce adjacent-level intra discal pressures and provide a more physiological overall cervical but also index- and adjacent-level range of motion (ROM) while maintaining sagittal alignment. Recent studies have also highlighted the potential limitations of TDR. Dynamic cervical implant (DCI) is a type of anterior decompression and cervical non-fusion implant that was initially conceived as a method to combine the potential advantages of fusion and TDR. The DCI is intended to provide controlled, limited flexion and extension-the primary motions in the sub axial cervical spine-that is greater than that seen with fusion, but less than that achieved with TDR .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Degenerative Disc Disease
    Keywords
    Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A calculated minimum sample of 50 patients with single or multiple symptomatic cervical DDD with radiculopathy and\or myelopathy not responding to non-surgical management will be needed. The sample will be randomly assigned for one of two equal groups (Group I (n=25); will undergo ACDF and Group II (n=25) will undergo DCI to detect an effect size of 0.42 in the rate of adjacent segment degeneration (main clinical and radiological outcomes), with an error probability of 0.05 and 80%
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group (1) (ACDF)
    Arm Type
    Active Comparator
    Arm Description
    All patients on this group will undergo Anterior Cervical Discectomy And Fusion
    Arm Title
    Group (2) (DCI)
    Arm Type
    Active Comparator
    Arm Description
    All patients on this group will undergo Dynamic Cervical Implant
    Intervention Type
    Procedure
    Intervention Name(s)
    Cervical spine surgery
    Intervention Description
    A standard anterior approach was made with discectomy sparing the cartilage, and with foraminal decompression. Complete excision of the posterior longitudinal ligament was routinely performed to complete neural decompression. Trial inserters were used to identify the proper implant size. Device under sizing may lead to poor fixation and implant migration. The largest possible device that can be safely placed should be selected to maximize device- endplate contact and to gain support from the apophyseal rim. The teeth of the implant were optimally fixated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if final imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO
    Primary Outcome Measure Information:
    Title
    Radiological outcome
    Description
    MRI grading for the degree of ASD (Mario Matsumato grading)
    Time Frame
    At 1 year follow up.
    Secondary Outcome Measure Information:
    Title
    Clinical outcome
    Description
    1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse
    Time Frame
    At 3 month .
    Title
    Radiological outcome (Plain x-ray)
    Description
    1- Cervical sagittal alignment C2 to C7 (Cobb angle) 5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae.
    Time Frame
    at 6 month.
    Title
    Radiological outcome (MSCT)
    Description
    1-implant fusion
    Time Frame
    At 1 year .
    Title
    clinical outcome
    Description
    Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse
    Time Frame
    At 3 month .
    Title
    radiological outcome
    Description
    2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment
    Time Frame
    at 6 month .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management Age older than 18 years Exclusion Criteria: ossification of posterior longitudinal ligament facet arthritis lack of motion or instability at the level of surgery fracture infection tumors osteoprosis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Saleh El Attar, Master
    Phone
    01014919050
    Email
    attar@med.aun.edu.eg

    12. IPD Sharing Statement

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    16205349
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    Hilibrand AS, Yoo JU, Carlson GD, Bohlman HH. The success of anterior cervical arthrodesis adjacent to a previous fusion. Spine (Phila Pa 1976). 1997 Jul 15;22(14):1574-9. doi: 10.1097/00007632-199707150-00009.
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    Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

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