Clinical trial NCT03103516: Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function
Official title: Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function: a Prospective, Multicenter, Non-randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 acute spinal cord injury patients (complete and incomplete) will undergo pre-hospital treatment in the Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center, and will receive in-hospital treatment in the Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. There were 100 patients undergoing epidural decompression surgery within 24 hours and 100 patients receiving surgery after 24 hours.
Primary purpose: TREATMENT

Brief summary: To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months.

Detailed description: Whether early epidural decompression surgery can restore neurological function in patients with acute spinal cord injury (complete and incomplete), and an effective time window for epidural decompression, are still controversial.

This trial will verify whether early epidural decompression surgery is more conducive to the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) compared with delayed surgery. This trial will begin in August 2017. Data analysis of 200 patients will be finished in December 2019. All results will be completed in December 2020. This trial will provide clinical evidences for the selection of timing of epidural decompression surgery in patients with complete and incomplete spinal cord injury.

Adverse events Adverse events will be obtained from patients or their legal representatives. Major adverse events will include: limb paralysis deterioration, re-operation, respirator use (more than 1 week), tracheostomy, septicemia, pneumonia, acute respiratory distress syndrome, atelectasis, other respiratory complications, wound infection (superficial and deep), urinary tract infection, other infections, gastrointestinal bleeding, peptic ulcer, intestinal obstruction, acute myocardial infarction, other heart events, pulmonary embolism, cerebrovascular complication, hepatic failure, renal failure, delirium and depression.

Statistical methods

1. All data will be analyzed using SPSS 19.0 software.
2. Normally distributed measurement data will be expressed as mean, SD, minimums, and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data will be presented as the percentage.
3. Measurement data among groups will be compared using two-sample t-test or Mann-Whitney U test.
4. Count data will be analyzed using chi square test or Fisher's exact test. Ranked data will be analyzed using Wilcoxon signed-rank test.

Sample size ASIA motor score is one of the main outcome measures. In accordance with a previous study (Chikuda et al., 2013), taking power = 0.8 with a significance level of α = 0.05, we will need 45 patients per group when the difference to be detected in the ASIA motor score between the groups is 12 points and the common standard deviation is 20. If we assume a patient loss rate of 20%, we will require 54 patients per group, totally 108 patients. We therefore aim to include 200 patients in accordance with previous conditions on acute spinal cord injury (complete and incomplete) treatment in participating units.

Data management

1. All data will be input into the spinal cord injury treatment database. After the completion of the study, the research group and third-party statistical staffs will carry out data collation and analysis.
2. The participating units are responsible for filling in the information database. Data consistency and logic will be checked by computer program combined with manual review. Any questions will be answered by the person in charge of the project and the main staff, and returned to the data management center, and then the data manager will modify and update the database.
3. All inspection procedures need to be repeated several times until there is no doubt. All changes and updates are required for recording and filing. It is strictly forbidden to use correction fluid or correction tape. All researchers are required to ensure that the data recorded in the case report forms are authentic.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000);
* Final diagnosis by spine CT and/or MRI;
* Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury;
* No other injury involving life, injury severity score \< 16;
* No anesthesia contraindication;
* No local skin infection, no severe soft tissue contusion, soft tissue condition of the operation area met the operation requirements;
* Age: 16-85 years old, irrespective of sex.

Exclusion Criteria:

* Active or recent severe infection
* Severe infectious diseases that need to be treated in infectious disease hospital;
* History of mental illness;
* History of metal allergy;
* Long-term alcohol abuse and drug abuse;
* Do not agree to participate in this trial; the legal representative of the patient refuses to sign informed consent;
* Poor compliance, cannot be followed up as required.

Primary outcomes:
measure: American Spinal Injury Association (ASIA) motor and sensory scores
timeFrame: at postoperative 6 months
Secondary outcomes:
measure: American Spinal Injury Association (ASIA) impairment scale
timeFrame: changes of week 1, month 1 and month 3 after surgery
measure: Evaluation of the incidence of complications
timeFrame: changes of week 1, month 1, month 3 and month 6 after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chaoyang Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department of Orthopedics, Peking University People's Hospital, Beijing, China
name: Baoguo Jiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sizheng Z, Boxuan H, Feng X, Dianying Z. A functional outcome prediction model of acute traumatic spinal cord injury based on extreme gradient boost. J Orthop Surg Res. 2022 Oct 12;17(1):451. doi: 10.1186/s13018-022-03343-7.