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CAP_2014: The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02030899
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
72.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cage fusion
  • Procedure: Plate fusion
 N/A

Detailed Description

cage: MC+® cage plate: atlantis® plate

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
ACDF with plate and autologous boneACDF with plate and autologous bone
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
Actual Study Start Date :
Dec 1, 2013
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cage

Cage filled with autologous bone

Procedure: Cage fusion
Randomized selection of surgery type
Other Names:
  • Use of stand-alone Cage filled with autologous bone

    		•
    Other: Plate

    Plate augmentation after iliac bone graft

    Procedure: Plate fusion
    Randomized selection of surgery type
    Other Names:
  • Use of Plate augmentation after autologous iliac bone graft

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fusion rate [2 years]

      The rate of interbody fusion at 2 years

    Secondary Outcome Measures

    1. Segmental angle [2 years]

      the segmental angle at the fused level

    2. cervical lordosis [2 years]

      The cervical lordosis at 2 years

    3. pain change [2 years]

      Visual analogue pain score

    4. functional status change. [2 years]

      Neck disability index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Single level degenerative cervical spine disease

    • aged 30 - 70

    • no improvement of symptom for 8 weeks of non-surgical treatment.

    • degeneration in other levels without stenosis, accepted

    Exclusion Criteria:

    • osteoporosis

    • disease with poor bone quality

    • Cancer

    • Previous cervical spine surgery

    • Multiple levels disease

    • Ossification of posterior longitudinal ligament

    • Kyphosis at the index level

    • Developmental stenosis (diameter of C7 spinal canal < 10mm)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Kee Chung, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02030899
    Other Study ID Numbers:
    • CAP_2014
    First Posted:
    Jan 9, 2014
    Last Update Posted:
    Apr 17, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Chun Kee Chung, Professor, Seoul National University Hospital
    Cervical vertebrae
    single
    degenerative disease
    Fusion
    Sagittal angle

    Study Results

    No Results Posted as of Apr 17, 2018