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A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

Seoul National University logo

Seoul National University

Status

Active, not recruiting

Conditions

Myelopathy
Radiculopathy, Cervical

Treatments

Device: Cage and Plate
Procedure: anterior cervical discectomy and fusion
Device: Cage alone

Study type

Interventional

Funder types

Other

Identifiers

NCT01911013
KSSS-001

Details and patient eligibility

About

The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.

Enrollment

500 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • degenerative cervical disease
  • radiculopathy or myelopathy refractory to conservative treatment
  • be scheduled to undergo one segment anterior cervical discectomy and fusion
  • age is more than 19 years old
  • all requirements of preoperative image studies are satisfied

Exclusion criteria

  • previous neck surgery or radiation treatments at neck area
  • fusion at adjacent segments
  • two segment fusion is expected
  • C2-3 or C7-T1
  • high risk for additional cervical surgery within one year
  • ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
  • inadequate radiological images
  • patient is not expected to be observed at long term follow-up (foreigner, international student)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Cage and Plate
Active Comparator group
Description:
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
Treatment:
Device: Cage and Plate
Procedure: anterior cervical discectomy and fusion
Cage alone
Experimental group
Description:
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
Treatment:
Procedure: anterior cervical discectomy and fusion
Device: Cage alone

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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