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

Study Overview
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Brief Summary
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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
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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 Neck Disability Index(NDI), the Visual Analog Scale(VAS) of neck pain, and the C2-7 Spine Cobb angle at postoperative 1 year.

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

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

Intervention / Treatment
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* Procedure: C3 laminectomy
* Procedure: C3 laminoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C3 laminectomy with C4-6 laminoplasty<br>Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. | Procedure: C3 laminectomy<br>* C3 laminectomy preserving semispinalis cervicis inserted into the axis.<br>|
| Active Comparator: C3-6 laminoplasty<br>Cervical myelopathy patients who underwent C3-6 laminoplasty. | Procedure: C3 laminoplasty<br>* Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Neck Disability Index (NDI) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. | 1 year | 
| posterior neck with visual analog scale (VAS) | Measuring pain intensity of the posterior neck with visual analog scale (VAS), rated 1 to 10 with 10 being the most severe pain level. | 1 year | 
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 month, 6 month, 12 month, 2 year, 3 year | 
| Radiological outcomes | Measuring C2-C3 lordosis angle, C4-C7 lordosis angle, T1 slope angle, T1 slope - 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. | 1year, 2 year, 3 year | 
| C2-C7 sagittal vertical axis (C2-C7 SVA) | distance between C2 plumb line and C7) by using standard lateral cervical x-ray series with the patients standing in a neutral position. | 1year, 2 year, 3 year | 
| C2-C3 interlaminar spontaneous fusion | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. | through study completion, an average of 2 year | 
| Estimated intraoperative blood loss | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. | Intraoperative | 
| Operative time | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laminoplasty, Laminectomy