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

Completed

• Conditions: Cervical Myelopathy; Ossification of Posterior Longitudinal Ligament in Cervical Region
• Interventions: Procedure: Intensive recovery management

• Registration Number: NCT04947891
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Study Start: 2017-12-06
• Primary Completion: 2020-06-15
• Study Completion: 2020-12-20
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Intensive recovery management	Patients will be treated with intensive recovery method after surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Feifei Zhou; 🇨🇳 Beijing, Beijing, China