Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02660268 |
| Other study ID # |
38RC14.455 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2016 |
| Est. completion date |
February 7, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital, Grenoble |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
