Hip Prosthesis InfectionOSCAR-PHNCT02660268
Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections
A study testing Clinical Pathway in people with Hip Prosthesis Infection, run by University Hospital, Grenoble at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis Infection
- What is being tested?
- Clinical Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 7 sitesFrance
- Study dates
- 21 Mar 2016to 7 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject < 18 years of age
- Inability to read and understand the participant's Information
- Pregnant women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Annecy Hospital
Annecy, 74000
Chambéry Hospital
Chambéry, 73000
University Hospital of Grenoble
Grenoble, 38700
Groupe Hospitalier Mutualiste de Grenoble.
Grenoble
Hospices Civils de Lyon
Lyon
Hôpital Nord-CHU Saint Etienne
Saint-Etienne
Voiron Hospital
Voiron, 38500
About this study
Official title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
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.
Read the 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
- Being tested
- Clinical Pathway
- Keywords
- Clinical pathway, Infection, Hip, Prosthesis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical PathwayOther
Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections
| Study group | Role | What they receive |
|---|---|---|
| Clinical pathway | Experimental | Patients in the experimental group will be followed according to the clinical pathway Receives: Other: Clinical Pathway |
| Control | No intervention | Patients in the control group will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Clinical cure
Measured: 12 months
Secondary outcomes (8)
Time duration between first clinical signs and diagnosis
Measured: 12 months
Time duration between diagnosis and therapeutic management
Measured: 12 months
Total duration of antibiotic therapy
Measured: 12 months
Conservation or removal of hip prosthesis
Measured: 12 months
Cumulative length of hospital stay
Measured: 12 months
Gap analysis between observed care and the clinical path
Measured: 12 months
Functional sequelae at one year
Measured: 12 months
Quality of life at one year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start21 Mar 2016
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Prosthesis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia PAVESE, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660268
- Sponsor's protocol ID
- 38RC14.455
- Acronym
- OSCAR-PH
- Status last verified
- May 2024
- First submitted
- 12 Jan 2016
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections
- ClinicalTrials.gov ID
- NCT02660268
- Acronym / sponsor ID
- OSCAR-PH / 38RC14.455
- Conditions
- Hip Prosthesis Infection
- Keywords
- Clinical pathway, Infection, Hip, Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pathway | Experimental | Other: Clinical PathwayPatients in the experimental group will be followed according to the clinical pathway |
| Control | No intervention | –Patients in the control group will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Subject < 18 years of age
- Inability to read and understand the participant's Information
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical PathwayImplementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections | Other | Clinical pathway |
Primary outcome
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
8 secondary outcomes
Time duration between first clinical signs and diagnosis
Time frame: 12 months
Time duration between diagnosis and therapeutic management
Time frame: 12 months
Total duration of antibiotic therapy
Time frame: 12 months
Conservation or removal of hip prosthesis
Time frame: 12 months
Cumulative length of hospital stay
Time frame: 12 months
Gap analysis between observed care and the clinical path
Time frame: 12 months
Functional sequelae at one year
Time frame: 12 months
Quality of life at one year
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
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Hip Prosthesis Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia PAVESE, MD principal investigator
University Hospital, Grenoble
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pathway in people with Hip Prosthesis Infection, run by University Hospital, Grenoble at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.