Cervical Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region
Conditions
Keywords
Cervical myelopathy, Ossification of posterior longitudinal ligament, Intensive recovery, Quality of life, Surgical outcomes
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.
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.
Interventions
PROCEDUREIntensive 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.
Sponsors
Peking University Third Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical spine mechanical analysis | 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 |
| Cervical spine functions | Preoperation to 1 year after surgery. | NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of pain | Preoperation to 1 year after surgery. | VAS score before surgery, at 3-month postoperative follow-up and 1-year follow |
| Neurological outcome | Preoperation to 1 year after surgery. | mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow |
| Outcome of quality of life | Preoperation to 1 year after surgery. | EQ-5D score before surgery, at 3-month postoperative follow-up and 1-year follow |
Countries
China
Outcome results
None listed