OSCAR-PHEvaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
Clinical Pathway
Infections
Other Study
Summary
Study start date: March 21, 2016
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.164 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Chambéry Hospital
Chambéry, FranceUniversity Hospital of Grenoble
Grenoble, FranceGroupe Hospitalier Mutualiste de Grenoble.
Grenoble, France