Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function

NCT03103516 | Unknown DMC

• 1 other identifier: PekingUPH_003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association (ASIA) motor and sensory scores

  To assess spinal nerve function. Evaluation criteria for neurological function after spinal cord injury: Neurological function will be evaluated in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000).

  at postoperative 6 months

Secondary Outcomes (2)

• American Spinal Injury Association (ASIA) impairment scale

  changes of week 1, month 1 and month 3 after surgery

• Evaluation of the incidence of complications

  changes of week 1, month 1, month 3 and month 6 after surgery

Study Arms (2)

early epidural decompression group

EXPERIMENTAL

The patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.

Procedure: early epidural decompression group

delayed epidural decompression group

EXPERIMENTAL

The patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.

Procedure: delayed epidural decompression group

Interventions

early epidural decompression group PROCEDURE

The patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.

early epidural decompression group

delayed epidural decompression group PROCEDURE

The patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.

delayed epidural decompression group

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (4)

Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• 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.

  PMID: 36224595 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Baoguo Jiang, Ph.D

  Department of Orthopedics, Peking University People's Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Xue, Ph.D

CONTACT

8618811331636; 317108233@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 6, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

CN (4)