Outcome of Old Patient With Articular With Articular Implant Infection

NCT05284331 | Terminated

• 1 other identifier: CHMS20001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Implant, Orthopedic, Infection or Inflammation

Keywords

Articular Implant Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

OTHER

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

Interventions

addition of two follow-up visits post infection 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

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Above criteria not met,
• Patient refusal,
• Mild cognitive impairment or more significant.

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

Location

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• PEJU Martin, Physician

  Centre Hospitalier Metropole Savoie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: March 17, 2022
• Study Start: March 3, 2021
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

FR (1)