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Trial record 6 of 47 for:    "Prosthetic Joint Infection"

Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection. (PSA-QOL)

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ClinicalTrials.gov Identifier: NCT02805803
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
VANINA MEYSSONNIER, Groupe Hospitalier Diaconesses Croix Saint-Simon

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.


Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Other: Quality of life questionary Not Applicable

Detailed Description:

Main objective:

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

Secondary objectives:

  1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
  2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
  3. Evaluation of PSA side effects
  4. Evaluation of nutritional status
  5. Evaluation of of PSA termination criteria

Methods:

The follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms.

Study type:

This is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI.

Sample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients.

Study duration: 6 years.

Recruitment period: 4 years.

Maximal duration of data collection: 2 years.

Investigator center: Single center study.

Mean patient inclusion per year: 15 patients per year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Quality of life questionary

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
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
Other Names:
  • Depressive symptoms questionary
  • Joint functional questionary




Primary Outcome Measures :
  1. Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
    Method assessment : Short Form 12 questionary (SF12)


Secondary Outcome Measures :
  1. 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
    Method assessment : Beck depression inventory (BDI)

  2. 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
    Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3. 3. Evaluation of PSA side effects [ Time Frame: 2 years ]
    Method assessment : anamnesis and clinical examination

  4. 4. Evaluation of nutritional status [ Time Frame: 2 years ]
    Method assessment : BMI and proteinuria measurement

  5. 5. Evaluation of PSA termination criteria [ Time Frame: 2 years ]

    Monitoring :

    • Treatment failure in case of :

      • Side effects
      • Relapse of the infection
      • Persistance of the infection
    • The patient wishes terminate the treatment because of :

      • Side effects
      • The infection is controlled



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805803


Contacts
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Contact: Younes KERROUMI, Doctorate (+33) 1 44 64 33 84 ykerroumi@hopital-dcss.org

Locations
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France
Groupe Hospitalier Dianconesses croix saint Simon Recruiting
Paris, Ile De France, France, 75020
Contact: Younes KERROUMI, Doctorate    01 44 64 33 84    ykerroumi@hopital-dcss.org   
Sponsors and Collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
Investigators
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Principal Investigator: VANINA MEYSSONNNIER, Doctorate Groupe Hospitalier Diaconesses Croix Saint-Simon

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Responsible Party: VANINA MEYSSONNIER, Infectious deseases specialist, Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT02805803     History of Changes
Other Study ID Numbers: ID RCB: 2015-A01702-47
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases