Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections (OSCAR-PH)

May 25, 2023 updated by: University Hospital, Grenoble

Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections

The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of surgical site infections following the orthopedic surgery is about 1%. The number of prosthesis infections is estimated between 2000 and 2500 new cases a year in France.

Multiple medical and surgical care strategies are possible depending on the acute or chronic presentation, early or delayed antibiotic therapy; antibiotic therapy alone or associated with joint lavage, or with a prosthesis change in one or in two stages; after a long or short period of time, with or without fitting spacer. The practices are very heterogeneous for chronic infections depending on the terrain on which infection occurs and modalities of antibiotic therapy remain controversial. The treatment failure rate at 1 year is estimated at 20%.

The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

Objectives: To determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure.

The secondary objectives are: To evaluate medical and surgical practices in diagnosis and treatment of hip prosthesis infections; identify the success factors and therapeutic failure of medical and surgical supported hip prosthesis infections in terms of clinical cure; determining management of quality indicators.

Methods: The clinical path will be developed by a committee of experts from the national and international recommendations, a review of the literature focused on the prosthesis conservation strategies and audit practices at the University Hospital of Grenoble.

The clinical path will be evaluated by an interventional trial clustered with control group, randomized, stepped wedge (inclusion staggered in time in 4 X 3 months) with an evaluation at one year.

The study population will include all patients treated for hip prosthesis infection in hospitals participating in the Alps, in a period of 16 months.

The primary endpoint will be the clinical cure at one year, defined as the absence of clinical signs of infection, inflammatory syndrome (C-Reactive Protein <10 mg / L), and radiological signs of infection.

Analysis: The association between the primary endpoint and the introduction of a clinical path will be quantified by the odds ratio estimated using a logistic regression model with adjustment for baseline characteristics of patients and inclusion of non-independence of observations.

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Annecy, France, 74000
        • Recruiting
        • Annecy Hospital
        • Contact:
        • Principal Investigator:
          • Virginie Vitrat-Hincky, MD
      • Chambéry, France, 73000
      • Grenoble, France, 38700
        • Recruiting
        • University hospital of Grenoble
        • Contact:
        • Principal Investigator:
          • Patricia Pavese, MD
        • Sub-Investigator:
          • Mylène Maillet, MD
        • Sub-Investigator:
          • Dominique Saragaglia, MD PhD
        • Sub-Investigator:
          • Jean-paul Stahl, MD PhD
        • Sub-Investigator:
          • Olivier Epaulard, MD PhD
        • Sub-Investigator:
          • Isabelle Pierre, MD
        • Sub-Investigator:
          • Charlotte Dentan, MD
        • Sub-Investigator:
          • Jean-paul Brion, MD
      • Grenoble, France
        • Recruiting
        • Groupe Hospitalier Mutualiste de Grenoble.
        • Contact:
        • Principal Investigator:
          • Nastasia El-Zeenni, MD
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Tristan FERRY
      • Saint-Étienne, France
      • Voiron, France, 38500

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

Description

Inclusion Criteria:

  • Subject ≥ 18 years of age. Having a first episode of hip prosthesis infection defined by an infectious disease physician on clinical , radiological and microbiological criteria according the clinical practice guidelines of the French-Language Infectious Diseases Society May 13, 2009
  • Signed Informed Consent
  • Supported in one of the participating center (hospitals of Arc Alpin)
  • Covered by health insurance

Exclusion Criteria:

  • Subject < 18 years of age
  • Inability to read and understand the participant's Information
  • Pregnant women

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical pathway
Patients in the experimental group will be followed according to the clinical pathway
Other: Clinical Pathway
Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections
No Intervention: Control
Patients in the control group will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure at 1 year of initial medical management, defined by the absence of the clinical signs of infection, the inflammatory syndrome (C- Reactive Protein <10 mg / L) and the radiological signs of infection
Time Frame: 12 months
Clinical cure
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time duration between first clinical signs and diagnosis
Time Frame: 12 months
12 months
Time duration between diagnosis and therapeutic management
Time Frame: 12 months
12 months
Total duration of antibiotic therapy
Time Frame: 12 months
12 months
Conservation or removal of hip prosthesis
Time Frame: 12 months
12 months
Cumulative length of hospital stay
Time Frame: 12 months
12 months
Gap analysis between observed care and the clinical path
Time Frame: 12 months
12 months
Functional sequelae at one year
Time Frame: 12 months
12 months
Quality of life at one year
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Patricia PAVESE, MD, University Hospital, Grenoble

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 (Actual)

March 21, 2016

Primary Completion (Actual)

March 20, 2023

Study Completion (Estimated)

March 20, 2024

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimated)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.455

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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