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

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 Overview

• Status: Completed
• Conditions: Cervical Myelopathy

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior Cervical Muscle Volume	the volume of Posterior Cervical Muscle	preoperation
Posterior Cervical Muscle Volume	the volume of Posterior Cervical Muscle	2 years after operation
C5 palsy	C5 nerve palsy	2 years after operation
axial syndrome	axial syndrome	2 years after operation
reoperation	reoperation	2 years after operation
door closing	door closing	2 years after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mJOA	modified Japanese orthopaedics association	2 years after operation
NDI	neck disability index	2 years after operation
VAS	visual analogue scale	2 years after operation
ROM	range of motion	2 years after operation

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Yu Sun, Dr., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (ACTUAL): August 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative Complications; Single Open-door Expansive Laminoplasty; Preserving the Unilateral Ligament With Muscle Complex; Effects on Posterior Cervical Muscle Volume
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Postoperative Complications
• Other Study ID Numbers: LM2020161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No