Cervical VertebraeCAP_2014NCT02030899
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
A study testing Cage fusion and Plate fusion in people with Cervical Vertebrae and Single, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cervical Vertebrae, Single, Degenerative Disease
- What is being tested?
- Cage fusion and Plate fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2013to 30 Dec 2019
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level degenerative cervical spine disease
- aged 30 - 70
- no improvement of symptom for 8 weeks of non-surgical treatment.
- degeneration in other levels without stenosis, accepted
Who cannot join
- osteoporosis
- disease with poor bone quality
- Cancer
- Previous cervical spine surgery
- Multiple levels disease
- Ossification of posterior longitudinal ligament
- Kyphosis at the index level
- Developmental stenosis (diameter of C7 spinal canal < 10mm)
Trial locations and contacts
1 site in 1 country.
About this study
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.
Read the detailed description
cage: MC+® cage plate: atlantis® plate
- Conditions
- Cervical Vertebrae, Single, Degenerative Disease
- Being tested
- Cage fusion, Plate fusion
- Keywords
- Cervical vertebrae, single, degenerative disease, Fusion, Sagittal angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cage fusionProcedure or surgery
Also called Use of stand-alone Cage filled with autologous bone
Randomized selection of surgery type
Plate fusionProcedure or surgery
Also called Use of Plate augmentation after autologous iliac bone graft
Randomized selection of surgery type
| Study group | Role | What they receive |
|---|---|---|
| Cage | Active comparator | Cage filled with autologous bone Receives: Procedure: Cage fusion |
| Plate | Other | Plate augmentation after iliac bone graft Receives: Procedure: Plate fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
The rate of interbody fusion at 2 years
Measured: 2 years
Secondary outcomes (4)
Segmental angle
the segmental angle at the fused level
Measured: 2 years
cervical lordosis
The cervical lordosis at 2 years
Measured: 2 years
pain change
Visual analogue pain score
Measured: 2 years
functional status change.
Neck disability index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start1 Dec 2013
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical VertebraeStudies 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
- Model description
- ACDF with plate and autologous bone
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030899
- Sponsor's protocol ID
- CAP_2014
- Acronym
- CAP_2014
- Status last verified
- Apr 2024
- First submitted
- 2 Jan 2014
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
- ClinicalTrials.gov ID
- NCT02030899
- Acronym / sponsor ID
- CAP_2014 / CAP_2014
- Conditions
- Cervical Vertebrae, Single, Degenerative Disease
- Keywords
- Cervical vertebrae, single, degenerative disease, Fusion, Sagittal angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 9 Jan 2014 (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 use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.
Detailed description
cage: MC+® cage plate: atlantis® plate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- ACDF with plate and autologous bone
| Arm | Type | Receives |
|---|---|---|
| Cage | Active comparator | Procedure: Cage fusionCage filled with autologous bone |
| Plate | Other | Procedure: Plate fusionPlate augmentation after iliac bone graft |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single level degenerative cervical spine disease
- aged 30 - 70
- no improvement of symptom for 8 weeks of non-surgical treatment.
- degeneration in other levels without stenosis, accepted
Key exclusion criteria (8 listed)
- osteoporosis
- disease with poor bone quality
- Cancer
- Previous cervical spine surgery
- Multiple levels disease
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 |
|---|---|---|
| Cage fusionAlso: Use of stand-alone Cage filled with autologous boneRandomized selection of surgery type | Procedure or surgery | Cage |
| Plate fusionAlso: Use of Plate augmentation after autologous iliac bone graftRandomized selection of surgery type | Procedure or surgery | Plate |
Primary outcome
Fusion rate
Time frame: 2 years
The rate of interbody fusion at 2 years
4 secondary outcomes
Segmental angle
Time frame: 2 years
cervical lordosis
Time frame: 2 years
pain change
Time frame: 2 years
functional status change.
Time frame: 2 years
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 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cage fusion and Plate fusion in people with Cervical Vertebrae and Single, 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 4 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
Fusion rate (time frame: 2 years). 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 17 Apr 2024.