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

NCT05019001 | Completed

• 1 other identifier: ChenxinPekingUTH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ossification of the Posterior Longitudinal Ligament

Keywords

OPLL; high occupation rate; laminoplasty; laminectomy with fusion

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (14)

• Operation time

  during operation

• blood loss

  during operation

• Rate of C5 nerve root palsy

  C5 nerve palsy after operation immediately

• hematoma incidence

  hematoma after operation immediately

• Rate of spinal cord injury

  spinal cord injury after operation immediately

Study Arms (2)

Laminoplasty

OTHER

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

Procedure: Laminoplasty

Laminectomy With Fusion

OTHER

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

Procedure: Laminectomy With Fusion

Interventions

Laminoplasty PROCEDURE

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

Laminoplasty

Laminectomy With Fusion PROCEDURE

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

Laminectomy With Fusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Ossification of Posterior Longitudinal Ligament

Interventions

Laminoplasty; Laminectomy; Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Neurosurgical Procedures; Surgical Procedures, Operative; Decompression, Surgical; Recombination, Genetic; Genetic Phenomena

Study Officials

• Xin Chen, Dr.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: August 24, 2021
• Study Start: March 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-06

Locations

CN (1)