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Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

Primary Purpose

Cervical Disc Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACD
ACDF
ACDA
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Degeneration focused on measuring Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with arm pain not responding to conservative treatment
  • lasted longer than 10 weeks
  • single level disc degeneration
  • mobile spine on dynamic lateral cervical X-rays

Exclusion Criteria:

  • severe cardiopulmonary comorbidity
  • suspected underlying malignant disease
  • radicular syndrome
  • spinal-cord compression syndrome
  • contraindication for radiography

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    grade 1

    grade 2

    grade 3

    Arm Description

    ACD

    ACDF

    ACDA

    Outcomes

    Primary Outcome Measures

    change of cervical alignment
    The Harrison posterior tangent method was used as an estimate for curvature

    Secondary Outcome Measures

    quality of life
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)

    Full Information

    First Posted
    November 26, 2017
    Last Updated
    November 30, 2017
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03360409
    Brief Title
    Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph
    Official Title
    Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2018 (Anticipated)
    Primary Completion Date
    January 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.
    Detailed Description
    This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Disc Degeneration
    Keywords
    Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    grade 1
    Arm Type
    Experimental
    Arm Description
    ACD
    Arm Title
    grade 2
    Arm Type
    Active Comparator
    Arm Description
    ACDF
    Arm Title
    grade 3
    Arm Type
    Active Comparator
    Arm Description
    ACDA
    Intervention Type
    Procedure
    Intervention Name(s)
    ACD
    Intervention Description
    Undertake anterior cervical discectomy without fusion
    Intervention Type
    Procedure
    Intervention Name(s)
    ACDF
    Intervention Description
    anterior cervical discectomy with fusion
    Intervention Type
    Procedure
    Intervention Name(s)
    ACDA
    Intervention Description
    anterior cervical discectomy with arthroplasty
    Primary Outcome Measure Information:
    Title
    change of cervical alignment
    Description
    The Harrison posterior tangent method was used as an estimate for curvature
    Time Frame
    1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years
    Secondary Outcome Measure Information:
    Title
    quality of life
    Description
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
    Time Frame
    1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with arm pain not responding to conservative treatment lasted longer than 10 weeks single level disc degeneration mobile spine on dynamic lateral cervical X-rays Exclusion Criteria: severe cardiopulmonary comorbidity suspected underlying malignant disease radicular syndrome spinal-cord compression syndrome contraindication for radiography
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    chen guo
    Phone
    8618055644700
    Email
    fantasy_g@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhenqi zhu
    Organizational Affiliation
    PekingUPH department of spinal surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

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