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

• ClinicalTrials.gov Identifier: NCT05019001
• Recruitment Status: Completed
• First Posted: August 24, 2021
• Last Update Posted: August 24, 2021
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Peking University Third Hospital

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.

Condition or disease	Intervention/treatment	Phase
Ossification of the Posterior Longitudinal Ligament	Procedure: Laminoplasty; Procedure: Laminectomy With Fusion	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: February 28, 2019
• Actual Study Completion Date: February 28, 2021

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. preoperative mJOA score [ Time Frame: preoperative ]
   Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
2. postoperative mJOA score [ Time Frame: postoperative at 3 months ]
   Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
3. postoperative mJOA score [ Time Frame: postoperative at 6 months ]
   Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
4. postoperative mJOA score [ Time Frame: postoperative at 1 year ]
   Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
5. postoperative mJOA score [ Time Frame: postoperative at 2 year ]
   Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
6. mJOA score change rate [ Time Frame: 3 months after surgery ]
   (Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
7. mJOA score change rate [ Time Frame: 6 months after surgery ]
   (Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
8. mJOA score change rate [ Time Frame: 1 year after surgery ]
   (Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
9. mJOA score change rate [ Time Frame: 2 years after surgery ]
   (Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%

Secondary Outcome Measures :

1. Operation time [ Time Frame: during operation ]
   Operation time during operation
2. blood loss [ Time Frame: during operation ]
   blood loss during operation, parameter is milliliter, which is caculated by anesthetist during operation
3. Rate of C5 nerve root palsy [ Time Frame: C5 nerve palsy after operation immediately ]
   Whether patient has deltoid muscle strength decrease after operation. If there is, it means to appear C5 palsy.
4. hematoma incidence [ Time Frame: hematoma after operation immediately ]
   hematoma after operation
5. Rate of spinal cord injury [ Time Frame: 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.
6. range of motion [ Time Frame: preoperation ]
   the movement range of cervical
7. range of motion [ Time Frame: 3 months after surgery ]
   the movement range of cervical
8. range of motion [ Time Frame: 6 months after surgery ]
   the movement range of cervical
9. range of motion [ Time Frame: 1 year after surgery ]
   the movement range of cervical
10. range of motion [ Time Frame: 2 years after surgery ]
    the movement range of cervical
11. neck pain VAS score [ Time Frame: 3 months after surgery ]
    Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
12. neck pain VAS score [ Time Frame: 6 months after surgery ]
    Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
13. neck pain VAS score [ Time Frame: 1 year after surgery ]
    Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
14. neck pain VAS score [ Time Frame: 2 years after surgery ]
    Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Beijing

Peking University Third Hospital

Beijing, Beijing, China, 100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

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

More Information

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05019001
• Other Study ID Numbers: ChenxinPekingUTH
• First Posted: August 24, 2021
• Last Update Posted: August 24, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking University Third Hospital:

OPLL; high occupation rate; laminoplasty; laminectomy with fusion

Additional relevant MeSH terms:

Ossification of Posterior Longitudinal Ligament; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes