Neck PainNCT06374680
C3 Laminectomy With Cervical Laminoplasty
An observational study of Neck Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- laminectomy at C3 level
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2017to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cervical stenosis who should undergo cervical laminoplasty
Who may be able to join
- cervical stenosis
Who cannot join
- metastatic tumor
- fracture
- previous cervical spine surgery (posterior approach)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
- Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.
- Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
- Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty.
Read the detailed description
Surgery is performed under general anesthesia as before, followed by posterior cervical incision. In one group, the cervical spine of the C3 is removed using a drill and punch and C4-6 laminoplasty will be performed. In the other group, C3-6 laminoiplasty will be performed. Postoperative suturing and subject management are the same as existing patient care policies. Follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. The degree of the neck pain is measured using NDI and VAS for each outpatient f/u.
- Conditions
- Neck Pain
- Being tested
- laminectomy at C3 level
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laminectomy at C3 levelProcedure or surgery
laminectomy at C3 level
| Study group | Role | What they receive |
|---|---|---|
| C3 laminectomy | laminectomy at C3 level and laminoplasty at C4-6 level Receives: Procedure: laminectomy at C3 level | |
| C3 laminoplasty | laminoplasty at C3-6 level Receives: Procedure: laminectomy at C3 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck pain
Numerical rating pain score on neck, 0~10, 0 is no pain, 10 is maximum pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Mar 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: This is because the same research has already been done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- 0 participants (actual)
- Target duration
- 2 Years
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, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374680
- Sponsor's protocol ID
- C3 ectomy
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2017
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
- ClinicalTrials.gov ID
- NCT06374680
- Acronym / sponsor ID
- C3 ectomy
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This is because the same research has already been done.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Apr 2024 (actual)
- 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.
- Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.
- Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
- Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty.
Detailed description
Surgery is performed under general anesthesia as before, followed by posterior cervical incision. In one group, the cervical spine of the C3 is removed using a drill and punch and C4-6 laminoplasty will be performed. In the other group, C3-6 laminoiplasty will be performed. Postoperative suturing and subject management are the same as existing patient care policies. Follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. The degree of the neck pain is measured using NDI and VAS for each outpatient f/u.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C3 laminectomy | – | Procedure: laminectomy at C3 levellaminectomy at C3 level and laminoplasty at C4-6 level |
| C3 laminoplasty | – | Procedure: laminectomy at C3 levellaminoplasty at C3-6 level |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical stenosis who should undergo cervical laminoplasty
Key inclusion criteria (1 listed)
- cervical stenosis
Key exclusion criteria (3 listed)
- metastatic tumor
- fracture
- previous cervical spine surgery (posterior approach)
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 |
|---|---|---|
| laminectomy at C3 levellaminectomy at C3 level | Procedure or surgery | C3 laminectomy, C3 laminoplasty |
Primary outcome
neck pain
Time frame: 1 year
Numerical rating pain score on neck, 0~10, 0 is no pain, 10 is maximum pain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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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, MD, PhD 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 Neck Pain, 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 3 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: withdrawn, as of the sponsor's last update on 22 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 was withdrawn before enrolling participants, so there are no results.
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?
neck pain (time frame: 1 year). 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 22 Apr 2024.