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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04947891
Other study ID # M2017310
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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