Symptomatic Epidural Hematoma After Cervical Spine SurgeryNCT05190276
Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery
An observational study of Symptomatic Epidural Hematoma After Cervical Spine Surgery, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptomatic Epidural Hematoma After Cervical Spine Surgery
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent cervical spine surgery in the Department of Orthopedics, Peking University Third Hospital between January 2009 and February 2019
Who may be able to join
- Patients with clinically and radiologically confirmed cervical spondylosis.
- Cervical spine surgery was performed in our hospital
Who cannot join
- Cervical trauma combined with fracture and dislocation.
- Cervical cancer.
- Cervical spine infection
- Upper cervical spine surgery alone
About this study
Official title: 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.
Read the 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.
- Keywords
- epidural hematoma, cervical spine surgery, Risk factors
- Medical subject headings
- Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The hematoma group | with symptomatic epidural hematoma after surgery | |
| The control group | without symptomatic epidural hematoma after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(visual analogue pain scale)
visual analogue pain scale, to evaluate patients' pain, form 0 to 10. more scores means more pain
Measured: 3 months after surgery
Frankel score
Postoperative Neurological Function，From A to E. Score A means complete paralyzed and E means no paralyzed
Measured: 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.
Measured: 3 months after surgery
Secondary outcomes (4)
whether patients occur hematoma after surgery
whether patients occur hematoma after surgery
Measured: From post operation immediately till 3 months after surgery
whether patients need emergency debridement
whether patients need emergency debridement caused by hematoma
Measured: 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
Measured: 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
Measured: From post operation immediately till 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2009
- Primary completion2 Mar 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Epidural Hematoma After Cervical Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190276
- Sponsor's protocol ID
- LM2020298
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Symptomatic Epidural Hematoma After Cervical Spine Surgery:a Retrospective Study
- ClinicalTrials.gov ID
- NCT05190276
- Acronym / sponsor ID
- LM2020298
- Keywords
- epidural hematoma, cervical spine surgery, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The hematoma group | – | –with symptomatic epidural hematoma after surgery |
| The control group | – | –without symptomatic epidural hematoma after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent cervical spine surgery in the Department of Orthopedics, Peking University Third Hospital between January 2009 and February 2019
Key inclusion criteria (2 listed)
- Patients with clinically and radiologically confirmed cervical spondylosis.
- Cervical spine surgery was performed in our hospital
Key exclusion criteria (4 listed)
- Cervical trauma combined with fracture and dislocation.
- Cervical cancer.
- Cervical spine infection
- Upper cervical spine surgery alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
4 secondary outcomes
whether patients occur hematoma after surgery
Time frame: From post operation immediately till 3 months after surgery
whether patients need emergency debridement
Time frame: From post operation immediately till 3 months after surgery
the place that occur hematoma
Time frame: From post operation immediately till 3 months after surgery
postoperative neurological recovery after treatment of hematoma
Time frame: From post operation immediately till 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Epidural Hematoma After Cervical Spine Surgery, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(visual analogue pain scale) (time frame: 3 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.