Outcome of Old Patient With Articular With Articular Implant Infection

Not Applicable

Terminated

• Conditions: Complications; Implant, Orthopedic, Infection or Inflammation
• Interventions: Other: addition of two follow-up visits post infection

• Registration Number: NCT05284331
• Lead Sponsor: Centre Hospitalier Metropole Savoie

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-03-03
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Status Verified: 2023-03
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
follow-up visit at 6 months and 1 year after inclusion.	addition of two follow-up visits post infection	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

Primary Outcome Measures

Name	Time	Method
Changes in the EQ-5D-5L quality of life score	1 year	the EQ-5D-5L questionnaire is a European quality of life scale: a first part with questions called "EQ-5D descriptive system" comprising 5 items: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; each item is rated from 1 to 5; 1 corresponding to "no problem", "5" representing "extreme problems or total disability Changes in the EQ-5D-5L quality of life score, 1 year after the onset of symptoms will be evaluated
Changes in the EQ-5D-VAS assessing the patient's general condition, completed by the patient	1 year	the EQ-5D-5L questionnaire is completed by a visual analogue scale, called "EQ-5D VAS"; it consists of a 20 cm line, graduated from 0 to 100, where the patient has to indicate how he/she evaluates his/her current state of health, 0 being the worst possible state and 100 the best; Changes in the "EQ-5D VAS" wil be evaluated 1 year after the onset of symptoms.

Trial Locations

Locations (1)

Centre Hospitalier Métropole Savoie; 🇫🇷 Chambéry, France