Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.

NCT02805803 | Unknown DMC

• 1 other identifier: ID RCB: 2015-A01702-47
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation. There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.

  Method assessment : Short Form 12 questionary (SF12)

  2 years

Secondary Outcomes (5)

• 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.

  2 years

• 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.

  2 years

• 3. Evaluation of PSA side effects

  2 years

• 4. Evaluation of nutritional status

  2 years

• 5. Evaluation of PSA termination criteria

  2 years

Study Arms (1)

Quality of life questionary

OTHER

During this study of health and care procedure, we will assess the quality of life of patients treated with suppressive antibiotique therapy using three questionaries: * SF12 * Beck * WOMAC

Other: Quality of life questionary

Interventions

Quality of life questionary OTHER

Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.

Also known as: Depressive symptoms questionary, Joint functional questionary

Quality of life questionary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study
• Non-eligible patient to surgical treatment
• Patient eligible to prolonged suppressive antibiotherapy

You may not qualify if:

• patient who does not meet eligibility criteria
• Patient living or traveling abroad for whom 2 years minimum follow up is impossible.
• Patient lawfully deprived of his liberty
• Patient not insured under social security scheme

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (2)

Groupe Hospitalier Diaconesses Croix saint Simon

Paris, 75020, France

RECRUITING

Groupe Hospitalier Dianconesses croix saint Simon

Paris, Île-de-France Region, 75020, France

RECRUITING

Study Officials

• Simon MARMOR, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Younes KERROUMI, MD

CONTACT

(+33) 1 44 64 33 84; ykerroumi@hopital-dcss.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 20, 2016
• Study Start: November 9, 2016
• Primary Completion: September 30, 2024
• Study Completion: June 30, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)