Clinical trial NCT05190276: Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery
Official title: Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery:a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Epidural Hematoma After Cervical Spine Surgery
Keywords: epidural hematoma
cervical spine surgery
Risk factors
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: VAS(visual analogue pain scale)
timeFrame: 3 months after surgery
measure: Frankel score
timeFrame: 3 months after surgery
measure: mJOA
timeFrame: 3 months after surgery
Secondary outcomes:
measure: whether patients occur hematoma after surgery
timeFrame: From post operation immediately till 3 months after surgery
measure: whether patients need emergency debridement
timeFrame: From post operation immediately till 3 months after surgery
measure: the place that occur hematoma
timeFrame: From post operation immediately till 3 months after surgery
measure: postoperative neurological recovery after treatment of hematoma
timeFrame: From post operation immediately till 3 months after surgery
Other outcomes:
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