Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hip Prosthesis Infection

Intervention / Treatment
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* Other: Clinical Pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Clinical cure | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical pathway, Infection, Hip, Prosthesis