The Establishment of the Integration of Surgery and Postoperative Intensive Recovery of Patients With CSM

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04947891

Collaborator

(none)

130

Enrollment

Location

36.5

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability.

Condition or Disease	Intervention/Treatment	Phase
Cervical Myelopathy Ossification of Posterior Longitudinal Ligament in Cervical Region	Procedure: Intensive recovery management

Detailed Description

In order to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management, and verify its safety, practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has 80 patients, treated with postoperative intensive recovery management, and the control group has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year follow-up.

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Establishment of the Integration of Posterior Approach Surgical Treatment and Postoperative Intensive Recovery Management of Patients With Degenerative Cervical Spine Myelopathy

Actual Study Start Date :

Dec 6, 2017

Actual Primary Completion Date :

Jun 15, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Study group Patients will be treated with intensive recovery method after surgery.	Procedure: Intensive recovery management Intensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
Control group Patients will be treated with regular recovery method after surgery.

Arm

Intervention/Treatment

Study group

Patients will be treated with intensive recovery method after surgery.

Procedure: Intensive recovery management

Intensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.

Control group

Patients will be treated with regular recovery method after surgery.

Outcome Measures

Primary Outcome Measures

Cervical spine mechanical analysis [Preoperation to 1 year after surgery.]
The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow
Cervical spine functions [Preoperation to 1 year after surgery.]
NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow

Secondary Outcome Measures

Outcome of quality of life [Preoperation to 1 year after surgery.]
EQ-5D score before surgery, at 3-month postoperative follow-up and 1-year follow
Outcome of pain [Preoperation to 1 year after surgery.]
VAS score before surgery, at 3-month postoperative follow-up and 1-year follow
Neurological outcome [Preoperation to 1 year after surgery.]
mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

(1) Age: 18~70 years. (2) Diagnosed as CSM or OPLL. (3) Going to receive C3-C7 open-door laminoplasty. (4) Agree to join this study and sign the informed consent.

Exclusion Criteria:

(1) Anterior and posterior combined surgery. (2) Posterior laminoplasty combined fusion. (3) Severe osteoporosis. (4) Morbid obesity. (5) patients with mental disorder. (6) patients with previous history of cervical spine surgery. (7) Abnormal laboratory report of liver function, kidney function and hematologic system.(8) Poor compliance. (9) Patients with other surgical contraindications. (10) Patients with intemperance or taking drugs. (11) Patients who joined other study within the last 3 months.