Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex

Completed

• Conditions: Cervical Myelopathy

• Registration Number: NCT05001685
• Lead Sponsor: Peking University Third Hospital

Brief Summary

In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Detailed Description

Expansive laminoplasty of posterior cervical canal has been widely used for the treatment of cervical spondylotic myelopathy with cervical spinal stenosis and ossification of the posterior longitudinal ligament since Hirabayashi et al. described it in the 1970s. Traditional single-door surgery requires extensive dissection of both paravertebral muscles and ligaments, and resect part of the spinous process. Postoperative complications (axial neck pain, stiffness, cervical kyphosis, reduced range of motion, etc.) are also related to that in degree. In order to reduce the damage to the posterior cervical structure and reduce the associated complications, in the 1990s, Yoshihiko Oshima et al. introduced the expansive laminoplasty of the spinal canal with one side of the posterior ligamentwith muscle complex attached to the spinous process. In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2020-08-31
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.Complete preoperative and postoperative diagnosis and treatment data of our hospital were available, and the follow-up time was ≥2 years.

Read More

Exclusion Criteria

• Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
door closing	2 years after operation	door closing
Posterior Cervical Muscle Volume	2 years after operation	the volume of Posterior Cervical Muscle
C5 palsy	2 years after operation	C5 nerve palsy
axial syndrome	2 years after operation	axial syndrome
reoperation	2 years after operation	reoperation

Secondary Outcome Measures

Name	Time	Method
VAS	2 years after operation	visual analogue scale
ROM	2 years after operation	range of motion
mJOA	2 years after operation	modified Japanese orthopaedics association
NDI	2 years after operation	neck disability index

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China