Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery

Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery:a Retrospective Study

The incidence and correlation of symptomatic epidural hematomas after cervical spine surgery was reviewed and analyzed, then it will provide reference to avoid the occurrence of this complication for the future clinical work.

Study Overview

• Status: Completed
• Conditions: Symptomatic Epidural Hematoma After Cervical Spine Surgery

Detailed Description

43 patients with symptomatic epidural hematoma after cervical spine surgery were enrolled in the Peking University Third hospital from January, 2009 to February, 2017. 86 patients without symptomatic epidural hematoma after cervical spine surgery during the same period were randomly selected as the control group. Demographic information (including gender, age, previous history, smoking history, etc.)，disease parameters (diagnosis, mJOA(modified Japanese Orthopaedics association) score, NDI(neck disability index) score)，laboratory and imaging parameters (including platelet, coagulation function, albumin, and OPLL)，segments，treatment parameters (surgical method, number of surgical segments, operative time, intraoperative blood loss, anesthesia time, whether to use implants) and postoperative conditions (including the time of hematoma occurrence, diagnostic method, emergency debridement operation time, patient improvement before and after debridement) were collected.Firstly, risk factors for symptomatic epidural hematoma after cervical surgery were selected by univariate analysis,then independent risk factors were screened by multiple Logistic regression analysis.

• Study Type: Observational
• Enrollment (Actual): 129

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cervical spine surgery in the Department of Orthopedics, Peking University Third Hospital between January 2009 and February 2019

Description

Inclusion Criteria:

• Patients with clinically and radiologically confirmed cervical spondylosis.
• Cervical spine surgery was performed in our hospital

Exclusion Criteria:

• Cervical trauma combined with fracture and dislocation.
• Cervical cancer.
• Cervical spine infection
• Upper cervical spine surgery alone

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
The hematoma group; with symptomatic epidural hematoma after surgery
The control group; without symptomatic epidural hematoma after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS(visual analogue pain scale)	visual analogue pain scale, to evaluate patients' pain, form 0 to 10. more scores means more pain	3 months after surgery
Frankel score	Postoperative Neurological Function，From A to E. Score A means complete paralyzed and E means no paralyzed	3 months after surgery
mJOA	Postoperative Neurological Function, modified Japanese orthopaedics association, From 0 to 17 scores. More scores mean better recovery after surgery. Score 0 means the most severe symptoms.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whether patients occur hematoma after surgery	whether patients occur hematoma after surgery	From post operation immediately till 3 months after surgery
whether patients need emergency debridement	whether patients need emergency debridement caused by hematoma	From post operation immediately till 3 months after surgery
the place that occur hematoma	the place that occur hematoma, to locate the place of hematoma from post operation immediately till 3 months after surgery	From post operation immediately till 3 months after surgery
postoperative neurological recovery after treatment of hematoma	To record neurological recovery after treatment of hematoma from post operation immediately till 3 months after surgery, use modified Japanese Orthopaedics association	From post operation immediately till 3 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): March 2, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Risk factors; epidural hematoma; cervical spine surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Epidural, Cranial; Hematoma, Epidural, Spinal
• Other Study ID Numbers: LM2020298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No