NCT02825381

Brief Summary

The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure. The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 7, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 8, 2014

Last Update Submit

July 1, 2016

Conditions

Infection

Keywords

ArthroplastyHip

Outcome Measures

Primary Outcomes (1)

  • infection of the prosthesis

    Rate of diagnosis infection of the prosthesis

    For the duration of hospital stay, up to 1 year]

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All cases operated on at the investigators institution between January 1, 2007 and November 30, 2010

You may qualify if:

  • Chronically infected total hip Arthroplasty
  • One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010

You may not qualify if:

  • Patient refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCOM, Hôpitaux Universitaires de Strasbourg

Illkirch-Graffenstaden, Bas Rhin, 67400, France

Location

MeSH Terms

Conditions

Infections

Central Study Contacts

Jean-Yves JENNY, MD

CONTACT

0388552145jean-yves.jenny@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

January 8, 2014

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 7, 2016

Record last verified: 2016-01

Locations

FR(1)