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

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ClinicalTrials.gov Identifier: NCT02660268
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Hip Prosthesis Infection Other: Clinical Pathway Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
Study Start Date : March 21, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time duration between first clinical signs and diagnosis [ Time Frame: 12 months ]
  2. Time duration between diagnosis and therapeutic management [ Time Frame: 12 months ]
  3. Total duration of antibiotic therapy [ Time Frame: 12 months ]
  4. Conservation or removal of hip prosthesis [ Time Frame: 12 months ]
  5. Cumulative length of hospital stay [ Time Frame: 12 months ]
  6. Gap analysis between observed care and the clinical path [ Time Frame: 12 months ]
  7. Functional sequelae at one year [ Time Frame: 12 months ]
  8. Quality of life at one year [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660268


Contacts
Contact: Patricia PAVESE, MD +33 4 76 76 39 41 PPavese@chu-grenoble.fr
Contact: Saber TOUATI, PhD +33 4 76 76 58 05 stouati1@chu-grenoble.fr

Locations
France
Annecy Hospital Not yet recruiting
Annecy, France, 74000
Contact: Virginie Vitrat-Hincky, MD       vvitrat@ch-annecygenevois.fr   
Principal Investigator: Virginie Vitrat-Hincky, MD         
Chambéry Hospital Recruiting
Chambéry, France, 73000
Contact: Emmanuel Forestier       emmanuel.forestier@ch-chambery.fr   
Principal Investigator: Emmanuel Forestier, MD         
University Hospital of Grenoble Not yet recruiting
Grenoble, France, 38700
Contact: Patricia Pavese, MD    +33 4 76 76 39 41    PPavese@chu-grenoble.fr   
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         
Voiron Hospital Not yet recruiting
Voiron, France, 38500
Contact: Mathilde Guillaume, MD       medecineb.guillaume@ch-voiron.fr   
Principal Investigator: Mathilde Guillaume, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Patricia PAVESE, MD University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02660268     History of Changes
Other Study ID Numbers: 38RC14.455
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by University Hospital, Grenoble:
Clinical pathway
Infection
Hip
Prosthesis

Additional relevant MeSH terms:
Infection
Communicable Diseases