Clinical trial NCT01911013: A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
Official title: A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Radiculopathy, Cervical
Myelopathy
Keywords: degenerative cervical disease
anterior cervical discectomy and fusion
plate and cage
cage alone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Spine Surgery
First posted: 2013-07-30
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Cervical fusion status
timeFrame: five year after surgery
Secondary outcomes:
measure: predisposing factor of non-union
timeFrame: one year after surgery
measure: risk factors of dysphagia
timeFrame: one year after surgery
measure: risk factors of dysphonia
timeFrame: one year after surgery
measure: factors for quality of life
timeFrame: one years after operation
measure: risk factors for adjacent segment degeneration
timeFrame: five year after surgery
measure: correlation between osteoporosis and fusion
timeFrame: one year after surgery
measure: relation between brace wearing and fusion
timeFrame: one year after surgery
measure: surgical outcomes for combined uncinectomy
timeFrame: one year after surgery
measure: change of neck motion after surgery
timeFrame: one year after surgery
measure: neuropathy after anterior cervical discectomy and fusion surgery
timeFrame: one year after surgery
measure: relation between the method of bone graft and fusion
timeFrame: one year after surgery
measure: analysis of complication rates after anterior cervical discectomy and fusion surgery
timeFrame: one year after surgery
measure: The correlation between existence of co-morbidity and surgical outcome
timeFrame: one year after surgery
measure: The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyounggi-do
city: Dongan
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Gyounggido
city: Dongan
country: Korea, Republic of
facility: Hallym University Hospital
state: Gyounggido
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyounggido
city: Seongnam
country: Korea, Republic of
facility: Bundang Jesaeng Hospital
state: Gyounggido
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyounggi
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA university
state: Gyoungido
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyoungnam
city: Iksan
country: Korea, Republic of
facility: Wonkwang University School of Medicine & Hospital
state: Jeonbuk
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Pohang
country: Korea, Republic of
facility: Pohang Semyung Christianity Hospital
state: Kyoungpook
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon ST. Mary's hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam severance hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: National Police Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin S. Yeom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: