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

Primary Purpose

Complications; Implant, Orthopedic, Infection or Inflammation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
addition of two follow-up visits post infection
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Complications; Implant, Orthopedic, Infection or Inflammation focused on measuring Articular Implant Infection

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Métropole Savoie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2021
Last Updated
March 28, 2023
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT05284331
Brief Title
Outcome of Old Patient With Articular With Articular Implant Infection
Acronym
OPWAI
Official Title
Outcome of Old Patient With Articular With Articular Implant Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Implant, Orthopedic, Infection or Inflammation
Keywords
Articular Implant Infection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
follow-up visit at 6 months and 1 year after inclusion.
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
addition of two follow-up visits post infection
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in the EQ-5D-5L quality of life score
Description
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
Time Frame
1 year
Title
Changes in the EQ-5D-VAS assessing the patient's general condition, completed by the patient
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEJU Martin, Physician
Organizational Affiliation
Centre Hospitalier Metropole Savoie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Métropole Savoie
City
Chambéry
ZIP/Postal Code
73000
Country
France

12. IPD Sharing Statement

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Outcome of Old Patient With Articular With Articular Implant Infection

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