A Retrospective Cohort Study of 15 Cases of Pelvic Fractu... | NCT06388915

Studies
A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion

NCT06388915

Sponsor

Weikang Chen

Status

Completed

Last Update Posted

Apr 29, 2024Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Pelvic Fracture
Morel-Lavallee Lesion

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2024Actual

Primary Completion Date

Mar 20, 2024Actual

Completion Date

Mar 23, 2024Actual

First Submitted Date

Apr 25, 2024

First Submission Date that Met QC Criteria

Apr 26, 2024

First Posted Date

Apr 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2024

Last Update Posted Date

Apr 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to treatment	Time of treatment for Morel-Lavallee lesion	10 days
Drainage volume	Drainage volume for Morel-Lavallee lesion	10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Provincial Hospital		Fuzhou	Fujian	350000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

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Browse Branches

Not provided