A Prospective Study Comparing the Efficacy of Laminoplasty and Laminectomy With Fusion for Ossification of the Posterior Longitudinal Ligament With High Occupation Rate in Cervical Spine

Not Applicable

Completed

• Conditions: Ossification of the Posterior Longitudinal Ligament
• Interventions: Procedure: Laminoplasty; Procedure: Laminectomy With Fusion

• Registration Number: NCT05019001
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods.

Detailed Description

Ossification of the posterior longitudinal ligament(OPLL) is a common spinal disease which can lead to neurological dysfunction and its morbidity is related to genetic factors. OPLL is usually found in cervical spine and characterized by hypertrophy and ossification of the posterior longitudinal ligament in the rear of the corresponding cervical vertebral body, which can encroach the space in the spinal canal and compress the spinal cord and/or nerve roots of the corresponding segments, resulting in sensory and motor disorders of the limbs as well as visceral autonomic nervous dysfunction, leading to neurological dysfunction and even high paraplegia. It not only causes great harm but also brings heavy economic and spiritual burden to patients and society.

Although the surgical treatments for OPLL include anterior and posterior approach, the anterior approach requires excellent equipment and rich operation experience for surgery doctor. Many articles showed significantly higher complications rate in anterior approach than that of posterior approach. Posterior approach surgery is considered to be one of the effective treatment methods for OPLL in cervical spine. In the posterior approach, there are two commonly recognized surgical procedures, laminoplasty and laminectomy with fusion. The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods. The purpose of this study is to make patients get the biggest medical benefits and to make a right surgical treatment strategy when doctors treating patients with high occupation rate OPLL in cervical spine.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-06
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients diagnosed by clinical symptoms, physical examination, X-ray, CT, and MRI with a high occupation rate of ossification of the posterior longitudinal ligament in the cervical spine need and can be treated surgically after preoperative examination.
• CT axial soft tissue window determine that the occupation rate of one or more spinal canal segments in C2-7 is more than 60%.
• Sagittal CT show ossification of more than 3 segments of the posterior longitudinal ligament of the cervical spine.
• Sign the written informed consent

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Exclusion Criteria

• Participating in other interventional clinical trials;
• Mental disorders or cognitive disorders;
• Heart and lung diseases;
• Nervous system diseases;
• Patients with serious liver and kidney diseases, tumors and infectious diseases;
• There are any other factors that the treated doctors consider unsuitable for inclusion or completion of the study.
• Patients with cervical spondylotic radiculopathy
• Patients with severe osteoporosis, skeletal fluorosis and other reasons for which laminoplasty is not feasible
• Patients with ossification of posterior longitudinal ligament of cervical spine with invasion rate ≥60% had cervical trauma
• The patient with cervical ligamentum flavum ossification was diagnosed at the C2-7 level
• Preoperative pregnancy test was performed to exclude pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminoplasty	Laminoplasty	A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Laminectomy With Fusion	Laminectomy With Fusion	Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Primary Outcome Measures

Name	Time	Method
postoperative mJOA score	postoperative at 2 year	Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
preoperative mJOA score	preoperative	Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
mJOA score change rate	2 years after surgery	(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%

Secondary Outcome Measures

Name	Time	Method
blood loss	during operation	blood loss during operation, parameter is milliliter, which is caculated by anesthetist during operation
Rate of C5 nerve root palsy	C5 nerve palsy after operation immediately	Whether patient has deltoid muscle strength decrease after operation. If there is, it means to appear C5 palsy.
Rate of spinal cord injury	spinal cord injury after operation immediately	Whether patient has spinal cord injury after operation. If there is, it means to appear sensory and motor impairments of limbs and trunk.
neck pain VAS score	2 years after surgery	Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
hematoma incidence	hematoma after operation immediately	hematoma after operation
range of motion	2 years after surgery	the movement range of cervical
Operation time	during operation	Operation time during operation

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China