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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Myelopathy; Ossification of Posterior Longitudinal Ligament in Cervical Region
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Feifei Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Measures

Outcome Measure	Measure Description	Time Frame
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.
Outcome of pain	VAS score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.
Neurological outcome	mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow	Preoperation to 1 year after surgery.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Feifei Zhou, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Cervical myelopathy; Ossification of posterior longitudinal ligament; Intensive recovery; Surgical outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Ossification, Heterotopic; Spinal Cord Diseases; Bone Marrow Diseases; Ossification of Posterior Longitudinal Ligament
• Other Study ID Numbers: M2017310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No