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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region

Intervention / Treatment
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* Procedure: Intensive recovery management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients will be treated with intensive recovery method after surgery. | Procedure: Intensive recovery management<br>* 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.<br>|
| Control group<br>Patients will be treated with regular recovery method after surgery. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical myelopathy, Ossification of posterior longitudinal ligament, Intensive recovery, Quality of life, Surgical outcomes