Outcome of Old Patient With Articular With Articular Implant Infection (OPWAI)

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.

Study Overview

• Status: Terminated
• Conditions: Complications; Implant, Orthopedic, Infection or Inflammation
• Intervention / Treatment: Other: addition of two follow-up visits post infection

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chambéry, France, 73000
    • Centre Hospitalier Metropole Savoie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the EQ-5D-5L quality of life score	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	1 year
Changes in the EQ-5D-VAS assessing the patient's general condition, completed by the patient	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.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Principal Investigator: PEJU Martin, Physician, Centre Hospitalier Metropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Articular Implant Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Inflammation; Infections; Communicable Diseases
• Other Study ID Numbers: CHMS20001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No