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

NCT04947891 | Completed DMC

• 1 other identifier: M2017310
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Myelopathy; Ossification of Posterior Longitudinal Ligament in Cervical Region

Keywords

Cervical myelopathy; Ossification of posterior longitudinal ligament; Intensive recovery; Quality of life; Surgical outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Outcome of quality of life

  Preoperation to 1 year after surgery.

• Outcome of pain

  Preoperation to 1 year after surgery.

• Neurological outcome

  Preoperation to 1 year after surgery.

Study Arms (2)

Study group

Patients will be treated with intensive recovery method after surgery.

Procedure: Intensive recovery management

Control group

Patients will be treated with regular recovery method after surgery.

Interventions

Intensive recovery management PROCEDURE

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.

Study group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Feifei Zhou

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Ossification of Posterior Longitudinal Ligament

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feifei Zhou, M.D.

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 1, 2021
• Study Start: December 6, 2017
• Primary Completion: June 15, 2020
• Study Completion: December 20, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)