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Dynamic Cervical Implant in Treatment of Cervical Disc Disease (DCI)

Primary Purpose

Cervical Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Discectomy and insertion of dynamic cervical implant in cervical disc herniation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Disease focused on measuring Dynamic cervical implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with single level cervical disc herniation ( C3 - C7 ).
  • Patients with cervical canal stenosis.
  • Patients with degenerative disc disease.
  • Patient with cervical disc disease not responding to medical treatment.
  • Age of the patient: any age.
  • Patients fit for surgery.

Exclusion Criteria:

  • Patients with multilevel cervical disc herniation.
  • Patients with segmental instability.
  • Patients with previous cervical spine surgery.
  • Patients with cervical kyphosis, active infection or known allergy to titanium.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    dynamic cervical implant

    discectomy

    Arm Description

    dynamic cervical implant in treatment of cervical disc disease

    insertion of dynamic cervical implant post cervical discectomy single level

    Outcomes

    Primary Outcome Measures

    Change of preoperative neck and radicular pain
    Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.
    Evaluation the motor power
    Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2020
    Last Updated
    November 8, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04627454
    Brief Title
    Dynamic Cervical Implant in Treatment of Cervical Disc Disease
    Acronym
    DCI
    Official Title
    Evaluation the Safety and Effectiveness of Dynamic Cervical Implants (DCI) in Treatment of Single Level Cervical Disc Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 25, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    December 15, 2021 (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
    Evaluation of outcome of DCI in treatment of cervical disc disease to patients admitted to neurosurgery department, Asyut University Hospitals. Give the effective treatment, pain control and can detect the best method could be used. Improve the outcome of these patients and decease rate of recurrence and complications.
    Detailed Description
    Anterior cervical decompression and fusion (ACDF) is the traditional method for treating degenerative cervical disc disease, providing satisfactory results in a high proportion of patients. However, stabilization of the treated segment may result in loss of mobility as a functional spinal unit and acceleration of degeneration of the adjacent disc. Re operations may be required to treat complications of fusion, such as recurrent radicular symptoms, non-union, graft collapse, or expulsion. Many previous studies have shown that loss of motion at the fused level is compensated by increased motion at adjacent segments after ACDF, which induces a high rate of degenerative change adjacent to the fused segment. Cervical non-fusion techniques have increasingly been accepted and applied by spine surgeons. As a main component of cervical non-fusion techniques, artificial cervical disc replacement provides good ROM of the cervical spine. Dynamic cervical stabilization with the DCI is a novel treatment approach for cervical disc disease that was initially conceived as a method to combine the potential advantages of fusion and total disc replacement. The first DCI was designed by Matgé in 2002 for treating cervical spondylosis. Paradigm spine introduced the second generation DCIs in 2005. A U-shaped appearance and axial elasticity are two the most significant characteristics. A prospective study by Matgé et al. in 2009 showed that the clinical efficacy was satisfactory after DCI replacement in 102 cases of cervical spondylosis and during a 1-year follow-up; there was neither device migration nor subsidence. The basic concept of the inter-body implant is to maintain a distraction-compression mechanism and so avoid possible collapse of the disc height. This is achieved using the special titanium-alloy DCI, which is bio compatible, available in various sizes, and provided with different foot prints. The U-shaped body provides support and has tooth-like serrations that resist expulsion or retropulsion of the implant when placed into the inter-vertebral space. With the end-plate left intact, osteogenesis and bone fusion are inhibited and no further hetero-topic fusions are supposed to occur. The initial clinical and radio graphic results with the DCI appear promising as an alternative to TDR and ACDF in the treatment of cervical disc disease. It affords maximal neurological improvement, along with maintenance of excellent clinical outcomes. The potential bio-mechanical advantages of DCI include the ability to maintain device-level motion and minimize the development of adjacent-segment disease, while protecting the facet joints from excessive stresses noted with other motion-preserving devices during lateral bending, axial rotation, and extension. The surgical technique included the use of a conventional anterior cervical approach and discectomy. As reported, disc replacement with DCI is a new strategy, in between ACDF & ADR. It is an intermediate solution in the spectrum of management strategies of cervical disc diseases. Immediate dynamic stability with good clinical response and no implant-related morbidity or complications are the main advantages of this implant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Disc Disease, Cervical Disc Herniation, Cervical Disc Degeneration
    Keywords
    Dynamic cervical implant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dynamic cervical implant
    Arm Type
    Experimental
    Arm Description
    dynamic cervical implant in treatment of cervical disc disease
    Arm Title
    discectomy
    Arm Type
    Experimental
    Arm Description
    insertion of dynamic cervical implant post cervical discectomy single level
    Intervention Type
    Procedure
    Intervention Name(s)
    Discectomy and insertion of dynamic cervical implant in cervical disc herniation
    Intervention Description
    The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation
    Primary Outcome Measure Information:
    Title
    Change of preoperative neck and radicular pain
    Description
    Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.
    Time Frame
    Two days post operative
    Title
    Evaluation the motor power
    Description
    Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with single level cervical disc herniation ( C3 - C7 ). Patients with cervical canal stenosis. Patients with degenerative disc disease. Patient with cervical disc disease not responding to medical treatment. Age of the patient: any age. Patients fit for surgery. Exclusion Criteria: Patients with multilevel cervical disc herniation. Patients with segmental instability. Patients with previous cervical spine surgery. Patients with cervical kyphosis, active infection or known allergy to titanium.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fahd Abdel Sabour Ahmed Mohammed, Rdr
    Phone
    00201029522851
    Email
    dfahd81@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdel Hai Moussa Abdel Latif, prof.
    Organizational Affiliation
    Assiut university hospital, neurosurgery department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed Elsayed Abo Kresha, prof.
    Organizational Affiliation
    Assiut university hospital, neurosurgery department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohammed Elsayed Mahmoud, Prof.
    Organizational Affiliation
    Assiut university hospital, neurosurgery department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/15541695/
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/9474724/
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    URL
    https://pubmed.ncbi.nlm.nih.gov/12435970/
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    URL
    https://pubmed.ncbi.nlm.nih.gov/19127159/
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/19262984/
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/10225797/
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/14748566/
    Description
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    URL
    https://europepmc.org/article/med/12902946
    Description
    Related Info
    URL
    https://pubmed.ncbi.nlm.nih.gov/18785525/
    Description
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    URL
    https://doi.org/10.3171/foc.2004.17.3.10
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/17355018/
    Description
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    URL
    https://thejns.org/downloadpdf/journals/j-neurosurg-spine/22/3/article-p237.pdf
    Description
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    URL
    https://www.banglajol.info/index.php/BMRCB/article/download/12884/9251
    Description
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    URL
    https://pubmed.ncbi.nlm.nih.gov/17721713/
    Description
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    URL
    https://www.google.com/search?rlz=1C1CHBD_arEG909EG909&sxsrf=ALeKk02OsmpENAj4A5tcvZVyY4KF8Rl3eA:1599003417496&q=18.%09De+Bowes+RM,+Grant+BD,+Bagby+GW,+Butts+MK.+Cervical+vertebral+interbody+fusion+in+the+horse:+a+comparative+study+of+bovine+xenografts+and+allografts+supported+by+stainless+steel+baskets.+Am+J+Vet+Res+1984;+45:+191-9&spell=1&sa=X&ved=2ahUKEwjJ4cb1j8nrAhUO1BoKHbpSBu8QkeECKAB6BAgKECo
    Description
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    Dynamic Cervical Implant in Treatment of Cervical Disc Disease

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