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

Not Applicable

Completed

Conditions: Myelopathy Cervical
Neck Pain
Ossification of Posterior Longitudinal Ligament
Cervical Spondylosis With Myelopathy
Kyphosis Post Surgical

Interventions: Procedure: C3 laminoplasty
Procedure: C3 laminectomy

Registration Number: NCT05006495

Lead Sponsor: Seoul National University Hospital

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

Inclusion Criteria

Cervical stenosis patients with or without cervical myelopathy.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C3-6 laminoplasty	C3 laminoplasty	Cervical myelopathy patients who underwent C3-6 laminoplasty.
C3 laminectomy with C4-6 laminoplasty	C3 laminectomy	Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.

Primary Outcome Measures

Name	Time	Method
C2-C7 Lordosis	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)	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.

Secondary Outcome Measures

Name	Time	Method
C2-C3 Interlaminar Spontaneous Fusion	at 2 year	Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.
T1 Slope Minus Cervical Lordosis	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.
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores	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).
T1 Slope	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.
C2-C3 Lordosis	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.
C4-C7 Lordosis	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.
Cervical Sagittal Vertical Axis (cSVA)	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.
Operative Time	Intraoperative	Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).
Posterior Neck With Numering Rating Scale (NRS-N)	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.
Upper Limb Pain With Numering Rating Scale (NRS-L)	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.
Estimated Intraoperative Blood Loss	Intraoperative	Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.