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

NCT ID: NCT05019001

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-02-28

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.

Conditions

Ossification of the Posterior Longitudinal Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laminoplasty

A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Group Type: OTHER

Laminoplasty

Intervention Type: PROCEDURE

A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Laminectomy With Fusion

Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Group Type: OTHER

Laminectomy With Fusion

Intervention Type: PROCEDURE

Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Interventions

Laminoplasty

A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Intervention Type: PROCEDURE

Laminectomy With Fusion

Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Chen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ChenxinPekingUTH

Identifier Type: -

Identifier Source: org_study_id