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

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947891
• Other study ID #: M2017310
• Status: Completed
• Start date: December 6, 2017
• Est. completion date: December 20, 2020

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 20, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Myelopathy
• Ossification of Posterior Longitudinal Ligament
• Spinal Cord Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Feifei Zhou	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	Cervical spine mechanical analysis	The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.
Primary	Cervical spine functions	NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.
Secondary	Outcome of quality of life	EQ-5D score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.
Secondary	Outcome of pain	VAS score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.
Secondary	Neurological outcome	mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.