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Completed

NCT Number: NCT05019001

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laminoplasty

Procedure

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

Laminectomy With Fusion

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Aug 24, 2021
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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