NCT05006495

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

Completed NA Results posted Last updated 21 June 2024

What this trial tests

NA trial testing C3 laminectomy in Myelopathy Cervical in 126 participants. Completed in 28 October 2022.

Timeline

20 March 2017

Primary endpoint
28 October 2022

28 October 2022

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	126
Start date	20 March 2017
Primary completion	28 October 2022
Estimated completion	28 October 2022
Sites	1 location across South Korea

Drugs / interventions tested

• C3 laminectomy
• C3 laminoplasty

Conditions studied

• Myelopathy Cervical — all drugs for Myelopathy Cervical →
• Kyphosis Post Surgical — all drugs for Kyphosis Post Surgical →
• Neck Pain — all drugs for Neck Pain →
• Ossification of Posterior Longitudinal Ligament — all drugs for Ossification of Posterior Longitudinal Ligament →

Sponsor

Seoul National University Hospital

Who can join

Adults 20 to 80, any sex, with Myelopathy Cervical or Kyphosis Post Surgical. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

C2-C7 Lordosis Primary · 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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	11.0	± 0.8
C3-6 Laminoplasty	10.9	± 0.8

the Neck Disability Index (NDI) Primary · 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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	12.8	± 1.0
C3-6 Laminoplasty	8.6	± 1.0

C2-C3 Lordosis Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	7.1	± 0.5
C3-6 Laminoplasty	3.2	± 0.5

C4-C7 Lordosis Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	3.9	± 0.8
C3-6 Laminoplasty	7.7	± 0.7

Cervical Sagittal Vertical Axis (cSVA) Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	31.6	± 1.4
C3-6 Laminoplasty	25.5	± 1.3

T1 Slope Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	25.8	± 0.6
C3-6 Laminoplasty	25.3	± 0.6

T1 Slope Minus Cervical Lordosis Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	15.0	± 1.0
C3-6 Laminoplasty	14.9	± 0.9

C2-C3 Interlaminar Spontaneous Fusion Secondary · at 2 year

Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	5
C3-6 Laminoplasty	26

EuroQol Five-dimensional Questionnaire (EQ-5D) Scores Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

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).

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	0.661	± 0.025
C3-6 Laminoplasty	0.743	± 0.024

Posterior Neck With Numering Rating Scale (NRS-N) Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	2.8	± 0.3
C3-6 Laminoplasty	2.0	± 0.3

Upper Limb Pain With Numering Rating Scale (NRS-L) Secondary · at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	3.7	± 0.4
C3-6 Laminoplasty	2.8	± 0.3

Estimated Intraoperative Blood Loss Secondary · Intraoperative

Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.

Group	Value	95% CI
C3 Laminectomy With C4-6 Laminoplasty	169	± 145
C3-6 Laminoplasty	182	± 159

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.