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CompletedNCT02030899CAP_2014Updated Apr 17, 2024

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

An interventional study of Cage fusion and Plate fusion in Cervical Vertebrae, Single and Degenerative Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

cage: MC+® cage plate: atlantis® plate

02

Conditions studied

  • Cervical Vertebrae
  • Single
  • Degenerative Disease

Keywords

  • Cervical vertebrae
  • single
  • degenerative disease
  • Fusion
  • Sagittal angle
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Cage

    Cage filled with autologous bone

    Procedure: Cage fusion

  • Other
    Plate

    Plate augmentation after iliac bone graft

    Procedure: Plate fusion

Interventions

  • ProcedureCage fusion

    Randomized selection of surgery type

    Also known as: Use of stand-alone Cage filled with autologous bone

  • ProcedurePlate fusion

    Randomized selection of surgery type

    Also known as: Use of Plate augmentation after autologous iliac bone graft

06

What researchers measure

Primary outcomes

  1. Fusion rate

    The rate of interbody fusion at 2 years

    Time frame: 2 years

Secondary outcomes

  1. Segmental angle

    the segmental angle at the fused level

    Time frame: 2 years

  2. cervical lordosis

    The cervical lordosis at 2 years

    Time frame: 2 years

  3. pain change

    Visual analogue pain score

    Time frame: 2 years

  4. functional status change.

    Neck disability index

    Time frame: 2 years

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02030899
Lead sponsor
Seoul National University Hospital
Responsible party
Chun Kee Chung (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 9, 2014
Start date
Dec 1, 2013
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Apr 17, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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