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

Completed

• Conditions: Symptomatic Epidural Hematoma After Cervical Spine Surgery

• Registration Number: NCT05190276
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-03-02
• Study Completion: 2020-10-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mJOA	3 months after surgery	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.
VAS(visual analogue pain scale)	3 months after surgery	visual analogue pain scale, to evaluate patients' pain, form 0 to 10. more scores means more pain
Frankel score	3 months after surgery	Postoperative Neurological Function，From A to E. Score A means complete paralyzed and E means no paralyzed

Secondary Outcome Measures

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