Pelvic FractureNCT06388915
A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion
An observational study of Pelvic Fracture and Morel-Lavallee Lesion, run by Weikang Chen at 1 site in China.
Trial summary
Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Fracture, Morel-Lavallee Lesion
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 23 Mar 2024
- 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: A total of 206 cases of pelvic fractures, including 15 cases with MLL complications, were collected between June 2017 and June 2023.
Who may be able to join
- (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.
Who cannot join
- (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.
Trial locations and contacts
1 site in 1 country.
About this study
Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries.
Read the detailed description
Inclusion criteria: (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.
Exclusion criteria: (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.
- Conditions
- Pelvic Fracture, Morel-Lavallee Lesion
- Keywords
- Morel-Lavallee Lesion, Pelvic Fracture
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Site of MLL
Site of the occurrence of Morel-Lavallee lesion
Measured: 5 days
Site of injury and Classification of pelvic fracture
Site of injury and Classification of pelvic fracture
Measured: 72 hours
Secondary outcomes (2)
Time to treatment
Time of treatment for Morel-Lavallee lesion
Measured: 10 days
Drainage volume
Drainage volume for Morel-Lavallee lesion
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start12 Mar 2024
- Primary completion20 Mar 2024
- Study completion23 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weikang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weikang Chen, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388915
- Sponsor's protocol ID
- K2202403004
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion
- ClinicalTrials.gov ID
- NCT06388915
- Acronym / sponsor ID
- K2202403004
- Conditions
- Pelvic Fracture, Morel-Lavallee Lesion
- Keywords
- Morel-Lavallee Lesion, Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weikang ChenUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 23 Mar 2024 (actual)
- First posted
- 29 Apr 2024 (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.
Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries.
Detailed description
Inclusion criteria: (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.
Exclusion criteria: (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 206 cases of pelvic fractures, including 15 cases with MLL complications, were collected between June 2017 and June 2023.
Key inclusion criteria (1 listed)
- (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.
Key exclusion criteria (1 listed)
- (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.
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
Site of MLL
Time frame: 5 days
Site of the occurrence of Morel-Lavallee lesion
Site of injury and Classification of pelvic fracture
Time frame: 72 hours
Site of injury and Classification of pelvic fracture
2 secondary outcomes
Time to treatment
Time frame: 10 days
Drainage volume
Time frame: 10 days
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 29 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture and Morel-Lavallee Lesion, run by Weikang Chen at 1 site in China.
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 1 inclusion and 1 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Site of MLL (time frame: 5 days). The study lists 2 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 29 Apr 2024.