Radiculopathy, CervicalNCT01911013
A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
A study testing anterior cervical discectomy and fusion, Cage and Plate and Cage alone in people with Radiculopathy, Cervical and Myelopathy, run by Seoul National University Hospital at 31 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Radiculopathy, Cervical, Myelopathy
- What is being tested?
- anterior cervical discectomy and fusion, Cage and Plate and Cage alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 31 sitesSouth Korea
- Study dates
- 1 Sep 2013to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
31 sites in 1 country.
31 sites in 1 country
South Korea31 sites
Inje University Busan Paik Hospital
Busan, 602-702
Inje University Haeundae Paik Hospital
Busan, 602-702
Pusan National University Hospital
Busan, 602-702
Kyungpook National University Hospital
Daegu, 602-702
Eulji University Hospital
Daejeon, 602-702
The Catholic University of Korea Daejeon ST. Mary's hospital
Daejeon, 602-702
Hallym University Dongtan Sacred Heart Hospital
Dongan, Gyounggido, 602-702
Hallym University Hospital
Dongan, Gyounggido, 602-702
Chonnam National University Hospital
Gwangju, 602-702
Chosun University Hospital
Gwangju, 602-702
Kwangju Christian Hospital
Gwangju, 602-702
Wonkwang University School of Medicine & Hospital
Iksan, Jeollabuk-do, 602-702
National Health Insurance Service Ilsan Hospital
Ilsan, Gyounggi-do, 602-702
Inje University Ilsan Paik Hospital
Ilsan, Gyounggido, 602-702
Dongguk University Ilsan Hospital
Ilsan, Gyounggi, 602-702
Inha University Hospital
Incheon, 602-702
The Catholic University of Korea, Incheon St. Mary's hospital
Incheon, 602-702
Pohang Semyung Christianity Hospital
Pohang, Kyoungpook, 602-702
Bundang Jesaeng Hospital
Seongnam, Gyounggido, 602-702
CHA Bundang Medical Center, CHA university
Seongnam, Gyoungido, 602-702
Seoul National University Hospital
Seoul, Jongno-gu, 110-744
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 602-702
Chung-Ang University Hospital
Seoul, 602-702
Gangnam severance hospital
Seoul, 602-702
Korea University Anam Hospital
Seoul, 602-702
National Police Hospital
Seoul, 602-702
Seoul National University Hospital
Seoul, 602-702
SMG-SNU Boramae Medical Center
Seoul, 602-702
Soonchunhyang University Seoul Hospital
Seoul, 602-702
VHS Medical Center
Seoul, 602-702
Pusan National University Yangsan Hospital
Yangsan, Gyoungnam, 602-702
About this study
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.
- Conditions
- Radiculopathy, Cervical, Myelopathy
- Being tested
- anterior cervical discectomy and fusion, Cage and Plate, Cage alone
- Keywords
- degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cervical discectomy and fusionProcedure or surgery
anterior cervical discectomy and fusion with anterior plating or not
Cage and PlateDevice
anterior cervical discectomy and fusion is performed using cervical cage and plate
Cage aloneDevice
anterior cervical discectomy and fusion is performed using cage alone with plate.
| Study group | Role | What they receive |
|---|---|---|
| Cage and Plate | Active comparator | anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system Receives: Procedure: anterior cervical discectomy and fusion; Device: Cage and Plate |
| Cage alone | Experimental | anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate Receives: Procedure: anterior cervical discectomy and fusion; Device: Cage alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical fusion status
Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.
Measured: five year after surgery
Secondary outcomes (14)
predisposing factor of non-union
Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.
Measured: one year after surgery
risk factors of dysphagia
a specific questionnaire is used for assessment for dysphagia after anterior cervical discectomy and fusion. For comparison of dysphagia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphagia is calculated for logistic regression analysis.
Measured: one year after surgery
risk factors of dysphonia
a specific questionnaire is used for assessment for dysphonia after anterior cervical discectomy and fusion. For comparison of dysphonia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphonia is calculated for logistic regression analysis.
Measured: one year after surgery
factors for quality of life
Firstly, total cost is calculated for each case. European Quality of Life-5 Dimensions is also used for assessment of quality of life after operation. Between two groups, quality of life per cost is evaluated.
Measured: one years after operation
risk factors for adjacent segment degeneration
The rates (%) of radiological and clinical adjacent segment degeneration is evaluated using X-ray and clinical evaluation in both groups. For statistical analysis, Chi-Square test is used for comparison of rates (%) for adjacent segment degeneration. Furthermore, logistic regression test is also used for calculating odds ratio for adjacent segment degeneration
Measured: five year after surgery
correlation between osteoporosis and fusion
The rates (%) of fusion is evaluated in relation to osteoporosis. For statistical analysis, Chi-Square test is used for comparison between osteoporosis group and non-osteoporosis group.
Measured: one year after surgery
relation between brace wearing and fusion
The rates (%) of fusion is evaluated using X-ray and CT scan according to kinds of brace in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates (%).
Measured: one year after surgery
surgical outcomes for combined uncinectomy
In relation with uncinectomy, the clinical outcomes (VAS, NDI) and radiological outcome (fusion rates(%)) is compared using t-test and Chi-square test.
Measured: one year after surgery
change of neck motion after surgery
Serial changes of whole cervical neck motion (degree) is evaluated and compared between pre- and post-operative states. statistical significance is evaluated using one-way ANOVA or paired t test.
Measured: one year after surgery
neuropathy after anterior cervical discectomy and fusion surgery
The occurrence rates(%) of neuropathic pain is evaluated using a specific questionnaires. Several factors to be associated with neuropathic pain is evaluated using logistic regression analysis.
Measured: one year after surgery
relation between the method of bone graft and fusion
The rates (%) of fusion is evaluated using X-ray and CT scan according to methods of bone graft in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates(%) in relation to the bone graft method.
Measured: one year after surgery
analysis of complication rates after anterior cervical discectomy and fusion surgery
After anterior cervical discectomy and fusion, complication rates (%) was evaluated, and this is compared between two groups. Further, factors to be associated with complication rates is assessed using Chi-square test
Measured: one year after surgery
The correlation between existence of co-morbidity and surgical outcome
The clinical and radiological outcomes is evaluated using VAS, NDI, and X-ray in relation with existence of coexistence. T-test and Chi-square test are used for statistical analysis for comparison between co-morbidity group and non-co-morbidity group.
Measured: one year after surgery
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
The surgical outcomes such as fusion rates(%), VAS, and NDI score were evaluated in relation with smoking history. For analysis, Chi-square and t-test are used for comparison between smoking group and non-smoking group.
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study start1 Sep 2013
- Primary completion1 Sep 2017
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Spine Surgery
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Jin S. Yeom, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911013
- Sponsor's protocol ID
- KSSS-001
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2013
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
- ClinicalTrials.gov ID
- NCT01911013
- Acronym / sponsor ID
- KSSS-001
- Conditions
- Radiculopathy, Cervical, Myelopathy
- Keywords
- degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Spine Surgery
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cage and Plate | Active comparator | Procedure: anterior cervical discectomy and fusion, Device: Cage and Plateanterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system |
| Cage alone | Experimental | Procedure: anterior cervical discectomy and fusion, Device: Cage aloneanterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior cervical discectomy and fusionanterior cervical discectomy and fusion with anterior plating or not | Procedure or surgery | Cage alone, Cage and Plate |
| Cage and Plateanterior cervical discectomy and fusion is performed using cervical cage and plate | Device | Cage and Plate |
| Cage aloneanterior cervical discectomy and fusion is performed using cage alone with plate. | Device | Cage alone |
Primary outcome
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.
14 secondary outcomes
predisposing factor of non-union
Time frame: one year after surgery
risk factors of dysphagia
Time frame: one year after surgery
risk factors of dysphonia
Time frame: one year after surgery
factors for quality of life
Time frame: one years after operation
risk factors for adjacent segment degeneration
Time frame: five year after surgery
correlation between osteoporosis and fusion
Time frame: one year after surgery
relation between brace wearing and fusion
Time frame: one year after surgery
surgical outcomes for combined uncinectomy
Time frame: one year after surgery
change of neck motion after surgery
Time frame: one year after surgery
neuropathy after anterior cervical discectomy and fusion surgery
Time frame: one year after surgery
relation between the method of bone graft and fusion
Time frame: one year after surgery
analysis of complication rates after anterior cervical discectomy and fusion surgery
Time frame: one year after surgery
The correlation between existence of co-morbidity and surgical outcome
Time frame: one year after surgery
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
Time frame: one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin S. Yeom, MD, PhD principal investigator
Seoul National University Bundang Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior cervical discectomy and fusion, Cage and Plate and Cage alone in people with Radiculopathy, Cervical and Myelopathy, run by Seoul National University Hospital at 31 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical fusion status (time frame: five year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.