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

Seoul National University Hospital30 sites in 1 country500 target enrollmentSeptember 1, 2013

ConditionsRadiculopathy, Cervical Myelopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Radiculopathy, Cervical
Sponsor: Seoul National University Hospital
Enrollment: 500
Locations: 30
Primary Endpoint: Cervical fusion status
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2013

End Date

September 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin S. Yeom

Associate Professor

Seoul National University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Cervical fusion status

Time Frame: five year after surgery

Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.

Secondary Outcomes

risk factors for adjacent segment degeneration(five year after surgery)
predisposing factor of non-union(one year after surgery)
risk factors of dysphagia(one year after surgery)
risk factors of dysphonia(one year after surgery)
factors for quality of life(one years after operation)
analysis of complication rates after anterior cervical discectomy and fusion surgery(one year after surgery)
correlation between osteoporosis and fusion(one year after surgery)
relation between brace wearing and fusion(one year after surgery)
surgical outcomes for combined uncinectomy(one year after surgery)
neuropathy after anterior cervical discectomy and fusion surgery(one year after surgery)
change of neck motion after surgery(one year after surgery)
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)(one year after surgery)
relation between the method of bone graft and fusion(one year after surgery)
The correlation between existence of co-morbidity and surgical outcome(one year after surgery)