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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

Not Applicable
Completed
Conditions
Cervical Vertebrae
Single
Degenerative Disease
Interventions
Procedure: Plate fusion
Procedure: Cage fusion
Registration Number
NCT02030899
Lead Sponsor
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.

Detailed Description

cage: MC+® cage plate: atlantis® plate

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlatePlate fusionPlate augmentation after iliac bone graft
CageCage fusionCage filled with autologous bone
Primary Outcome Measures
NameTimeMethod
Fusion rate2 years

The rate of interbody fusion at 2 years

Secondary Outcome Measures
NameTimeMethod
cervical lordosis2 years

The cervical lordosis at 2 years

Segmental angle2 years

the segmental angle at the fused level

pain change2 years

Visual analogue pain score

functional status change.2 years

Neck disability index

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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