NCT06388915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

8 days

First QC Date

April 25, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

Morel-Lavallee LesionPelvic Fracture

Outcome Measures

Primary Outcomes (2)

  • Site of MLL

    Site of the occurrence of Morel-Lavallee lesion

    5 days

  • Site of injury and Classification of pelvic fracture

    Site of injury and Classification of pelvic fracture

    72 hours

Secondary Outcomes (2)

  • Time to treatment

    10 days

  • Drainage volume

    10 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 206 cases of pelvic fractures, including 15 cases with MLL complications, were collected between June 2017 and June 2023.

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate student in bone surgery

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 29, 2024

Study Start

March 12, 2024

Primary Completion

March 20, 2024

Study Completion

March 23, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations