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

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.

Study Overview

• Status: Completed
• Conditions: Ossification of the Posterior Longitudinal Ligament
• Intervention / Treatment: Procedure: Laminoplasty; Procedure: Laminectomy With Fusion

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laminoplasty; A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament	Procedure: Laminoplasty; A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Other: Laminectomy With Fusion; Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament	Procedure: Laminectomy With Fusion; Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative mJOA score	Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms	preoperative
postoperative mJOA score	Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms	postoperative at 3 months
postoperative mJOA score	Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms	postoperative at 6 months
postoperative mJOA score	Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms	postoperative at 1 year
postoperative mJOA score	Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms	postoperative at 2 year
mJOA score change rate	(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%	3 months after surgery
mJOA score change rate	(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%	6 months after surgery
mJOA score change rate	(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%	1 year after surgery
mJOA score change rate	(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%	2 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Operation time during operation	during operation
blood loss	blood loss during operation, parameter is milliliter, which is caculated by anesthetist during operation	during operation
Rate of C5 nerve root palsy	Whether patient has deltoid muscle strength decrease after operation. If there is, it means to appear C5 palsy.	C5 nerve palsy after operation immediately
hematoma incidence	hematoma after operation	hematoma after operation immediately
Rate of spinal cord injury	Whether patient has spinal cord injury after operation. If there is, it means to appear sensory and motor impairments of limbs and trunk.	spinal cord injury after operation immediately
range of motion	the movement range of cervical	preoperation
range of motion	the movement range of cervical	3 months after surgery
range of motion	the movement range of cervical	6 months after surgery
range of motion	the movement range of cervical	1 year after surgery
range of motion	the movement range of cervical	2 years after surgery
neck pain VAS score	Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain	3 months after surgery
neck pain VAS score	Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain	6 months after surgery
neck pain VAS score	Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain	1 year after surgery
neck pain VAS score	Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain	2 years after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Xin Chen, Dr., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: OPLL; laminoplasty; high occupation rate; laminectomy with fusion
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Ossification, Heterotopic; Ossification of Posterior Longitudinal Ligament
• Other Study ID Numbers: ChenxinPekingUTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No