Cervical Disc DiseaseNCT01011569
Comparison of Cage Versus Plate in One Level Cervical Disc Disease
An observational study of Cervical Disc Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cervical Disc Disease
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2004to Dec 2013
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who needs surgery due to cervical disc disease
Who may be able to join
- Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.
Who cannot join
- We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease
There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.
Read the detailed description
Prospective study was started from April 2004 after permission by our Institutional Review Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. Operation method was randomized using the table of random sampling numbers. All operations were performed with standard anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.
- Conditions
- Cervical Disc Disease
- Keywords
- difference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cage | patient who underwent stand alone cage insertion after discectomy | |
| plate | patient who underwent plate fixation and autologous ilia bone graft after discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level
Measured: 1/3/6/12/24/36 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startApr 2004
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
- Investigators
- Chun Kee Chung, professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011569
- Sponsor's protocol ID
- CAP trial
- Status last verified
- Apr 2018
- First submitted
- 10 Nov 2009
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim CH, Chung CK, Hahn S. Autologous iliac bone graft with anterior plating is advantageous over the stand-alone cage for segmental lordosis in single-level cervical disc disease. Neurosurgery. 2013 Feb;72(2):257-65; discussion 266. doi: 10.1227/NEU.0b013e31827b94d4.
PubMed 23149973Lee SE, Chung CK, Kim CH. Difference in canal encroachment by the fusion mass between anterior cervical discectomy and fusion with bone autograft and anterior plating, and stand-alone cage. J Clin Neurosci. 2016 Jul;29:121-7. doi: 10.1016/j.jocn.2015.10.039. Epub 2016 May 24.
PubMed 27234609
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT01011569
- Acronym / sponsor ID
- CAP trial
- Conditions
- Cervical Disc Disease
- Keywords
- difference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2009 (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.
There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.
Detailed description
Prospective study was started from April 2004 after permission by our Institutional Review Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. Operation method was randomized using the table of random sampling numbers. All operations were performed with standard anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cage | – | –patient who underwent stand alone cage insertion after discectomy |
| plate | – | –patient who underwent plate fixation and autologous ilia bone graft after discectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who needs surgery due to cervical disc disease
Key inclusion criteria (1 listed)
- Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.
Key exclusion criteria (1 listed)
- We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level
Time frame: 1/3/6/12/24/36 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Results publication: PubMed 23149973Kim CH, Chung CK, Hahn S. Autologous iliac bone graft with anterior plating is advantageous over the stand-alone cage for segmental lordosis in single-level cervical disc disease. Neurosurgery. 2013 Feb;72(2):257-65; discussion 266. doi: 10.1227/NEU.0b013e31827b94d4.
- Derived from this study: PubMed 27234609Lee SE, Chung CK, Kim CH. Difference in canal encroachment by the fusion mass between anterior cervical discectomy and fusion with bone autograft and anterior plating, and stand-alone cage. J Clin Neurosci. 2016 Jul;29:121-7. doi: 10.1016/j.jocn.2015.10.039. Epub 2016 May 24.
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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.
Chun Kee Chung, professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Disease, run by Seoul National University Hospital at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level (time frame: 1/3/6/12/24/36 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011569, which also lists 2 linked publications.
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 17 Apr 2018.