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
Primary Purpose
Ossification of the Posterior Longitudinal Ligament
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laminoplasty
Laminectomy With Fusion
Sponsored by
About this trial
This is an interventional treatment trial for Ossification of the Posterior Longitudinal Ligament focused on measuring OPLL, high occupation rate, laminoplasty, laminectomy with fusion
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
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Laminoplasty
Laminectomy With Fusion
Arm Description
A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Outcomes
Primary Outcome Measures
preoperative mJOA score
Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Secondary Outcome Measures
Operation time
Operation time during operation
blood loss
blood loss during operation, parameter is milliliter, which is caculated by anesthetist 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.
hematoma incidence
hematoma after operation
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.
range of motion
the movement range of cervical
range of motion
the movement range of cervical
range of motion
the movement range of cervical
range of motion
the movement range of cervical
range of motion
the movement range of cervical
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Full Information
NCT ID
NCT05019001
First Posted
June 20, 2021
Last Updated
August 19, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05019001
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ossification of the Posterior Longitudinal Ligament
Keywords
OPLL, high occupation rate, laminoplasty, laminectomy with fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laminoplasty
Arm Type
Other
Arm Description
A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Arm Title
Laminectomy With Fusion
Arm Type
Other
Arm Description
Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Intervention Type
Procedure
Intervention Name(s)
Laminoplasty
Intervention Description
A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Intervention Type
Procedure
Intervention Name(s)
Laminectomy With Fusion
Intervention Description
Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Primary Outcome Measure Information:
Title
preoperative mJOA score
Description
Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Time Frame
preoperative
Title
postoperative mJOA score
Description
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Time Frame
postoperative at 3 months
Title
postoperative mJOA score
Description
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Time Frame
postoperative at 6 months
Title
postoperative mJOA score
Description
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Time Frame
postoperative at 1 year
Title
postoperative mJOA score
Description
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Time Frame
postoperative at 2 year
Title
mJOA score change rate
Description
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Time Frame
3 months after surgery
Title
mJOA score change rate
Description
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Time Frame
6 months after surgery
Title
mJOA score change rate
Description
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Time Frame
1 year after surgery
Title
mJOA score change rate
Description
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
Operation time
Description
Operation time during operation
Time Frame
during operation
Title
blood loss
Description
blood loss during operation, parameter is milliliter, which is caculated by anesthetist during operation
Time Frame
during operation
Title
Rate of C5 nerve root palsy
Description
Whether patient has deltoid muscle strength decrease after operation. If there is, it means to appear C5 palsy.
Time Frame
C5 nerve palsy after operation immediately
Title
hematoma incidence
Description
hematoma after operation
Time Frame
hematoma after operation immediately
Title
Rate of spinal cord injury
Description
Whether patient has spinal cord injury after operation. If there is, it means to appear sensory and motor impairments of limbs and trunk.
Time Frame
spinal cord injury after operation immediately
Title
range of motion
Description
the movement range of cervical
Time Frame
preoperation
Title
range of motion
Description
the movement range of cervical
Time Frame
3 months after surgery
Title
range of motion
Description
the movement range of cervical
Time Frame
6 months after surgery
Title
range of motion
Description
the movement range of cervical
Time Frame
1 year after surgery
Title
range of motion
Description
the movement range of cervical
Time Frame
2 years after surgery
Title
neck pain VAS score
Description
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Time Frame
3 months after surgery
Title
neck pain VAS score
Description
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Time Frame
6 months after surgery
Title
neck pain VAS score
Description
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Time Frame
1 year after surgery
Title
neck pain VAS score
Description
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Dr.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
We'll reach out to this number within 24 hrs