NCT04947891

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Myelopathy
• Ossification of Posterior Longitudinal Ligament in Cervical Region

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-06
• Primary completion: 2020-06-15
• Completion: 2020-12-20
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

1 site across 1 country: China