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

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001685
• Other study ID #: LM2020161
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cervical Myelopathy
• Postoperative Complications
• Spinal Cord Diseases

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