Myelopathy CervicalNCT05006495

Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

A study testing C3 laminectomy and C3 laminoplasty in people with Myelopathy Cervical and Kyphosis Post Surgical, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Myelopathy Cervical, Kyphosis Post Surgical, Neck Pain
What is being tested?: C3 laminectomy and C3 laminoplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteSouth Korea
Study dates: 20 Mar 2017to 28 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Cervical stenosis patients with or without cervical myelopathy.

Who cannot join

Metastatic cancer patients.
Any combined fracture.
Previous surgery to cervical spine.
inflammatory joint disease
psychiatric illness

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, Korea, 03080

Other trials in South Korea

About this study

Official title: Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Read the detailed description

Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.

There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1~3 year

Conditions: Myelopathy Cervical, Kyphosis Post Surgical, Neck Pain, Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Being tested: C3 laminectomy, C3 laminoplasty
Keywords: Laminoplasty, Laminectomy
Medical subject headings: Neck Pain, Ossification of Posterior Longitudinal Ligament

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C3 laminectomyProcedure or surgery
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
C3 laminoplastyProcedure or surgery
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

Study groups in NCT05006495
Study group	Role	What they receive
C3 laminectomy with C4-6 laminoplasty	Experimental	Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. Receives: Procedure: C3 laminectomy
C3-6 laminoplasty	Active comparator	Cervical myelopathy patients who underwent C3-6 laminoplasty. Receives: Procedure: C3 laminoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

C2-C7 Lordosis
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
the Neck Disability Index (NDI)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

Secondary outcomes (11)

C2-C3 Lordosis
Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C4-C7 Lordosis
Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Cervical Sagittal Vertical Axis (cSVA)
Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope
Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope Minus Cervical Lordosis
Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C2-C3 Interlaminar Spontaneous Fusion
Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.
Measured: at 2 year
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Posterior Neck With Numering Rating Scale (NRS-N)
Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Upper Limb Pain With Numering Rating Scale (NRS-L)
Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Measured: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Estimated Intraoperative Blood Loss
Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.
Measured: Intraoperative
Operative Time
Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201728 Oct 2022

First posted16 Aug 2021
Study start20 Mar 2017
Primary completion28 Oct 2022
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Myelopathy 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
Model description: A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty
Masking: Single blind
Who is masked: Participant
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05006495
Sponsor's protocol ID: 1610-136-804
Status last verified: Jan 2024
First submitted: 30 Jul 2021
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6.
PubMed 32387294
Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068.
PubMed 32941312
Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100.
PubMed 33086255
Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974.
PubMed 27851661
Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. doi: 10.1097/01.brs.0000186332.66490.ba.
PubMed 16284593

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 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 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
ClinicalTrials.gov ID: NCT05006495
Acronym / sponsor ID: 1610-136-804
Conditions: Myelopathy Cervical, Kyphosis Post Surgical, Neck Pain, Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Keywords: Laminoplasty, Laminectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: 20 Mar 2017 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 16 Aug 2021 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty

Arm	Type	Receives
C3 laminectomy with C4-6 laminoplasty	Experimental	Procedure: C3 laminectomyCervical myelopathy patients who underwent C3 laminectomy with laminoplasty.
C3-6 laminoplasty	Active comparator	Procedure: C3 laminoplastyCervical myelopathy patients who underwent C3-6 laminoplasty.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Cervical stenosis patients with or without cervical myelopathy.

Key exclusion criteria (5 listed)

Metastatic cancer patients.
Any combined fracture.
Previous surgery to cervical spine.
inflammatory joint disease
psychiatric illness

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
C3 laminectomyC3 laminectomy preserving semispinalis cervicis inserted into the axis.	Procedure or surgery	C3 laminectomy with C4-6 laminoplasty
C3 laminoplastyConventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.	Procedure or surgery	C3-6 laminoplasty

Primary outcome

C2-C7 Lordosis
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
the Neck Disability Index (NDI)
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.

11 secondary outcomes

C2-C3 Lordosis
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C4-C7 Lordosis
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Cervical Sagittal Vertical Axis (cSVA)
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope Minus Cervical Lordosis
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C2-C3 Interlaminar Spontaneous Fusion
Time frame: at 2 year
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Posterior Neck With Numering Rating Scale (NRS-N)
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Upper Limb Pain With Numering Rating Scale (NRS-L)
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Estimated Intraoperative Blood Loss
Time frame: Intraoperative
Operative Time
Time frame: Intraoperative

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C3 Laminectomy With C4-6 Laminoplasty	61	51
C3-6 Laminoplasty	61	58

Primary outcome: C2-C7 Lordosis

Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements). Least squares mean (Standard Error). Unit: °

Measure	C3 Laminectomy With C4-6 Laminoplasty n = 51	C3-6 Laminoplasty n = 58
Value	11.0 (0.8)	10.9 (0.8)

Primary outcome: the Neck Disability Index (NDI)

Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements). Least squares mean (Standard Error). Unit: score

Measure	C3 Laminectomy With C4-6 Laminoplasty n = 51	C3-6 Laminoplasty n = 58
Value	12.8 (1.0)	8.6 (1.0)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C3 Laminectomy With C4-6 Laminoplasty	0 of 61 (0%)	0 of 61 (0%)	0 of 61
C3-6 Laminoplasty	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32387294Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6.
Background: PubMed 32941312Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068.
Background: PubMed 33086255Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100.
Background: PubMed 27851661Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974.
Background: PubMed 16284593Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. doi: 10.1097/01.brs.0000186332.66490.ba.
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 study chair

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?

A study testing C3 laminectomy and C3 laminoplasty in people with Myelopathy Cervical and Kyphosis Post Surgical, 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 5 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 21 Jun 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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

C2-C7 Lordosis (time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)). The study lists 2 primary outcomes in all. 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 NCT05006495, which also lists 5 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 21 Jun 2024.