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

NCT ID: NCT02660268

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2024-02-07

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.

Conditions

Hip Prosthesis Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clinical pathway

Patients in the experimental group will be followed according to the clinical pathway

Group Type: EXPERIMENTAL

Clinical Pathway

Intervention Type: OTHER

Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections

Control

Patients in the control group will receive standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Pathway

Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia PAVESE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Annecy Hospital

Annecy, , France

Chambéry Hospital

Chambéry, , France

University Hospital of Grenoble

Grenoble, , France

Groupe Hospitalier Mutualiste de Grenoble.

Grenoble, , France

Hospices Civils de Lyon

Lyon, , France

Hôpital Nord-CHU Saint Etienne

Saint-Etienne, , France

Voiron Hospital

Voiron, , France

Countries

France

Other Identifiers

38RC14.455

Identifier Type: -

Identifier Source: org_study_id