NCT03581669

Brief Summary

We want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

June 26, 2018

Last Update Submit

March 1, 2021

Conditions

ElderlyAcetabular FracturesCerclage Acetabular FracturesTotal Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • harris hip score

    outcome after cerclage and THA

    1 year

Study Arms (1)

THA + cerclage acetabulum

Device: Cerclage and total hip arthroplasty

Interventions

Cerclage and total hip arthroplastyDEVICE

acetabular fractures in the elderly treated with cerclage acetabulum and total hip arthroplasty

THA + cerclage acetabulum

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

elderly patients who sustained an acetabular fracture

You may qualify if:

  • elderly (\>60Years)
  • acetabular fracture

You may not qualify if:

  • Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Mouhsine E, Garofalo R, Borens O, Blanc CH, Wettstein M, Leyvraz PF. Cable fixation and early total hip arthroplasty in the treatment of acetabular fractures in elderly patients. J Arthroplasty. 2004 Apr;19(3):344-8. doi: 10.1016/j.arth.2003.08.020.

    PMID: 15067649BACKGROUND

Biospecimen

Retention: NONE RETAINED

cerclage and THA

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Vanderschot Paul, MD, Phd

    UZ Leuven

    PRINCIPAL INVESTIGATOR

  • Molenaers Guy, MD, Phd

    UZ Leuven

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 10, 2018

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 2, 2021

Record last verified: 2021-03

Locations

BE(1)