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NCT Number: NCT05190276

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

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.

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Key information

Conditions

Symptomatic Epidural Hematoma After Cervical Spine Surgery Hematoma Hematoma, Epidural, Spinal Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. VAS(visual analogue pain scale)

    Time frame: 3 months after surgery

    visual analogue pain scale, to evaluate patients' pain, form 0 to 10. more scores means more pain

  2. Frankel score

    Time frame: 3 months after surgery

    Postoperative Neurological Function，From A to E. Score A means complete paralyzed and E means no paralyzed

  3. mJOA

    Time frame: 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.

Secondary outcomes

  1. whether patients occur hematoma after surgery

    Time frame: From post operation immediately till 3 months after surgery

    whether patients occur hematoma after surgery

  2. whether patients need emergency debridement

    Time frame: From post operation immediately till 3 months after surgery

    whether patients need emergency debridement caused by hematoma

  3. the place that occur hematoma

    Time frame: 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

  4. postoperative neurological recovery after treatment of hematoma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2019
Study completion
2020
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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