Clinical trial NCT04947891: The Establishment of the Integration of Surgery and Postoperative Intensive Recovery of Patients With CSM
Official title: The Establishment of the Integration of Posterior Approach Surgical Treatment and Postoperative Intensive Recovery Management of Patients With Degenerative Cervical Spine Myelopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 130
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical spine mechanical analysis
timeFrame: Preoperation to 1 year after surgery.
measure: Cervical spine functions
timeFrame: Preoperation to 1 year after surgery.
Secondary outcomes:
measure: Outcome of quality of life
timeFrame: Preoperation to 1 year after surgery.
measure: Outcome of pain
timeFrame: Preoperation to 1 year after surgery.
measure: Neurological outcome
timeFrame: Preoperation to 1 year after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Feifei Zhou
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Feifei Zhou, M.D.
role: STUDY_CHAIR
References: