Clinical trial NCT02660268: Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections
Official title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Prosthesis Infection
Keywords: Clinical pathway
Infection
Hip
Prosthesis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Time duration between first clinical signs and diagnosis
timeFrame: 12 months
measure: Time duration between diagnosis and therapeutic management
timeFrame: 12 months
measure: Total duration of antibiotic therapy
timeFrame: 12 months
measure: Conservation or removal of hip prosthesis
timeFrame: 12 months
measure: Cumulative length of hospital stay
timeFrame: 12 months
measure: Gap analysis between observed care and the clinical path
timeFrame: 12 months
measure: Functional sequelae at one year
timeFrame: 12 months
measure: Quality of life at one year
timeFrame: 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Annecy Hospital
city: Chambéry
country: France
facility: Chambéry Hospital
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble.
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Saint-Étienne
country: France
facility: Hôpital Nord-CHU Saint Etienne
city: Voiron
country: France
facility: Voiron Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Patricia PAVESE, MD
role: PRINCIPAL_INVESTIGATOR
References: