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NCT Number: NCT04947891

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

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.

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Key information

Conditions

Cervical Myelopathy Bone Diseases Musculoskeletal Diseases Ossification of Posterior Longitudinal Ligament Ossification of Posterior Longitudinal Ligament in Cervical Region Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feifei Zhou

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cervical spine mechanical analysis

    Time frame: Preoperation to 1 year after surgery.

    The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow

  2. Cervical spine functions

    Time frame: Preoperation to 1 year after surgery.

    NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow

Secondary outcomes

  1. Outcome of quality of life

    Time frame: Preoperation to 1 year after surgery.

    EQ-5D score before surgery, at 3-month postoperative follow-up and 1-year follow

  2. Outcome of pain

    Time frame: Preoperation to 1 year after surgery.

    VAS score before surgery, at 3-month postoperative follow-up and 1-year follow

  3. Neurological outcome

    Time frame: Preoperation to 1 year after surgery.

    mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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