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

NCT ID: NCT05190276

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2020-10-01

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.

Conditions

Symptomatic Epidural Hematoma After Cervical Spine Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

The hematoma group

with symptomatic epidural hematoma after surgery

No interventions assigned to this group

The control group

without symptomatic epidural hematoma after surgery

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LM2020298

Identifier Type: -

Identifier Source: org_study_id