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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05001685
Other study ID # LM2020161
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date June 1, 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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. Exclusion Criteria: - Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up

Study Design


Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Posterior Cervical Muscle Volume the volume of Posterior Cervical Muscle preoperation
Primary Posterior Cervical Muscle Volume the volume of Posterior Cervical Muscle 2 years after operation
Primary C5 palsy C5 nerve palsy 2 years after operation
Primary axial syndrome axial syndrome 2 years after operation
Primary reoperation reoperation 2 years after operation
Primary door closing door closing 2 years after operation
Secondary mJOA modified Japanese orthopaedics association 2 years after operation
Secondary NDI neck disability index 2 years after operation
Secondary VAS visual analogue scale 2 years after operation
Secondary ROM range of motion 2 years after operation
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