Prosthetic Hip Infections: Prospective Study (PHIPS)

February 13, 2018 updated by: Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon

Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years

Data from large prospective cohort studies of prosthetic joint infections are lacking.

Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.

Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

Study Overview

Status

Completed

Conditions

Detailed Description

Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population

  • all patients who consented to participate in the study with prosthetic hip infections treated by:
  • debridement-synovectomy for acute infection or with one-stage or two-stage
  • exchange arthroplasty or resection arthroplasty for chronic infection
  • antibiotic therapy

Outcome:

  • Follow-up: minimum of 2 years
  • Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths

Study Type

Observational

Enrollment (Actual)

347

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Diaconesses Croix Saint-Simon Hospital Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hip arthroplasty infection who underwent surgery and received antibiotic therapy in a specialized French orthopaedic center for bone and joint infection.

Description

Inclusion Criteria:

  • Patients with hip arthroplasty infection
  • Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection
  • Antibiotic therapy
  • Signed informed consent

Exclusion Criteria:

  • Prolonged suppressive antibiotic therapy
  • No surgical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of reinfection (relapse and new infection)
Time Frame: 2 years
The aim of this study was to prospectively determine the incidence of reinfection in patients with prosthetic hip infection after two years of follow up.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and causes of mechanical revision
Time Frame: 2 years
2 years
Incidence and causes of death: infection or treatment related death, unrelated death
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Investigators

  • Principal Investigator: Valerie ZELLER, MD, Diaconesses Croix Saint-Simon Hospital Group, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 2, 2002

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 10, 2015

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHDCSS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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