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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 (CAP_2014)

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ClinicalTrials.gov Identifier: NCT02030899
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Chun Kee Chung, Seoul National University Hospital

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
Cervical Vertebrae Single Degenerative Disease Procedure: Cage fusion Procedure: Plate fusion Not Applicable

Detailed Description:
cage: MC+® cage plate: atlantis® plate

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: ACDF 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 : December 1, 2013
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cage
Cage filled with autologous bone
Procedure: Cage fusion
Randomized selection of surgery type
Other Name: Use of stand-alone Cage filled with autologous bone

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




Primary Outcome Measures :
  1. Fusion rate [ Time Frame: 2 years ]
    The rate of interbody fusion at 2 years


Secondary Outcome Measures :
  1. Segmental angle [ Time Frame: 2 years ]
    the segmental angle at the fused level

  2. cervical lordosis [ Time Frame: 2 years ]
    The cervical lordosis at 2 years

  3. pain change [ Time Frame: 2 years ]
    Visual analogue pain score

  4. functional status change. [ Time Frame: 2 years ]
    Neck disability index



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030899


Contacts
Contact: Chi Heon Kim, Associated Professor +82-2-2072-3398 chiheon1@snu.ac.kr
Contact: Chun Kee Chung, Professor +82-2-2072-2352 chungc@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chi Heon Kim, MD, PhD    +82-2-2072-2358    chiheon1@snu.ac.kr   
Principal Investigator: Chun Kee Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Chun Kee Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02030899     History of Changes
Other Study ID Numbers: CAP_2014
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Chun Kee Chung, Seoul National University Hospital:
Cervical vertebrae
single
degenerative disease
Fusion
Sagittal angle