Treatment of Acetabular Fractures in Elderly Patients | NCT03929536

Studies
Treatment of Acetabular Fractures in Elderly Patients

NCT03929536

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jun 4, 2020Actual

Enrollment

211Actual

Phase

Not provided

Conditions

Acetabular 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

Jun 2020

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 27, 2019Actual

Primary Completion Date

Jun 2, 2020Actual

Completion Date

Jun 2, 2020Actual

First Submitted Date

Apr 24, 2019

First Submission Date that Met QC Criteria

Apr 24, 2019

First Posted Date

Apr 29, 2019Actual

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

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

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

This retrospective study investigates surgical treatment of acetabular fractures in elderly patients (>60 years of age), either undergoing joint-preserving surgery or joint- replacement. 1 year- outcome with regard to mobility and autonomy is assessed.

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

211Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in living arrangements	preservation of autonomy investigated by assessment of living arrangements: at home (by oneself, with a partner, with professional support), residential home for the elderly with occasional support, nursing home)	at baseline (right after surgery) and 1 year after surgery

Secondary Outcomes

Measure	Description	Time Frame
number of rehospitalisations	number of rehospitalisations	single time point assessment 1 year after surgery
number of re-surgeries	number of re-surgeries

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgical treatment of acetabular fracture between 2009 and 2018

Exclusion Criteria:

pathological fractures due to neoplasm or metastasis
status after implantation of an endoprosthesis

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

patients with acetabular fracture between 2009 and 2018 treated at the Department of Orthopedic and Trauma Surgery of University Hospital Basel

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franziska Saxer, Dr. med	Department of Orthopaedics and Traumatology, University Hospital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedics and Trauma Surgery (DOTS).		Basel		4031	Switzerland