Pelvic Fractures in the Elderly | NCT03476824

Studies
Pelvic Fractures in the Elderly

NCT03476824

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Pelvic Fracture

Interventions

Not provided

Countries

Switzerland

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

Mar 2023

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

Jan 1, 2006Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Mar 19, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 26, 2018Actual

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

Mar 15, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the project is to predict the patient under conservative therapy as a function of the patient Classification of Rommens and Hofmann and other potential prognostic factors. A corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.

Detailed Description

Not provided

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

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	number of patients who died within one year after pelvic fracture	from pelvic fracture until year 1
loss of independence	loss of independence defined as number of patients leaving their own home and starting to live in a retirement home or asylum within one year after pelvic fracture	from pelvic fracture until year 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pelvic fracture after low-energy trauma
Treatment in the years 2006 to 2016
patients equal to or older than 60 years

Exclusion Criteria:

Pelvic fracture after a high-energy space
Pathological fracture in the area of a tumor or a bony metastasis
Existence of a documented refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The patients are filtered out of our electronic patient system on the basis of the diagnosis "pelvic ring fracture". Subsequently, patients under the age of 60 and patients after high-energy trauma are excluded.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michaela Ramser, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Switzerland, Traumatology		Basel		4031	Switzerland

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

Not provided

Browse Branches

Not provided