Outcome of Old Patient With Articular With Articular Implant Infection

NCT ID: NCT05284331

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2023-03-28

Brief Summary

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Articular Implant Infection (AII) is itself a complicated diagnosis and a challenging condition to treat. In elderly patients, the application of existing recommendations is impeded by multiple frailties For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, whitch aim this is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.

Detailed Description

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Articular Implant Infection (AII) is itself a complicated diagnosis (diagnosis confirmation, pathogen identification, with appropriate samples) and a challenging condition to treat (long antibiotic exposure, repeated surgery, complex implant change). This condition requires a good cooperation between surgeon and infectious disease specialist, with a comprehension of each one's constraint. In elderly patients, the application of existing recommendations is impeded by multiple frailties (malnutrition, loss of autonomy, polypathology) which make each decision crucial. Indeed, from the choice of surgery to antibiotics management, all medical decision can induce more adverse events than in younger patients. For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, based on the evaluation of the EQ-5D-5L score during one year after AAI diagnosis in patients older than 75. The investigators evaluate this score and compare different groups of patients, according to age, nutrition status, Charlson comorbidity index, hospital stay length, and loss of autonomy, among others. The aim of this study is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.

Conditions

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Complications; Implant, Orthopedic, Infection or Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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follow-up visit at 6 months and 1 year after inclusion.

addition of a follow-up visit at 6 months and 1 year after inclusion. No treatment will be given specifically for this study. Other visits are part of the normal and usual rhythm of follow-up and evaluation of treatment in these patients

Group Type OTHER

addition of two follow-up visits post infection

Intervention Type OTHER

Addition of an additional follow-up visit 6 months post infection and one follow-up visit 1 year post infection.

No treatment will be given specifically for this study. The change in medical management will only be modified by the addition of these 2 consultations at 6 months and 1 year post infection

Interventions

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addition of two follow-up visits post infection

Addition of an additional follow-up visit 6 months post infection and one follow-up visit 1 year post infection.

No treatment will be given specifically for this study. The change in medical management will only be modified by the addition of these 2 consultations at 6 months and 1 year post infection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* hospitalized in infectious diseases, surgery, post-emergency unit, or geriatrics,
* diagnosed with a hip or knee prosthesis infection in the previous month according to the SPILF criteria (2009)(1).

Exclusion Criteria

* Above criteria not met,
* Patient refusal,
* Mild cognitive impairment or more significant.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PEJU Martin, Physician

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Metropole Savoie

Locations

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Centre Hospitalier Métropole Savoie

Chambéry, , France

Site Status

Countries

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France

Other Identifiers

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CHMS20001

Identifier Type: -

Identifier Source: org_study_id

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