Quality of Life Assessment in Patients Undergoing Prolong... | NCT02805803

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

NCT02805803

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Status

Unknown status

Last Update Posted

Sep 21, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Prosthetic Joint Infection

Interventions

Quality of life questionary

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2016Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Jun 15, 2016

First Submission Date that Met QC Criteria

Jun 15, 2016

First Posted Date

Jun 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2023

Last Update Posted Date

Sep 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SMARMOR, Director, Groupe Hospitalier Diaconesses Croix Saint-SimonPrincipal Investigator

Lead Sponsor

Groupe Hospitalier Diaconesses Croix Saint-SimonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Main objective:

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

Secondary objectives:

Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Evaluation of PSA side effects
Evaluation of nutritional status
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.	Method assessment : Short Form 12 questionary (SF12)	2 years

Secondary Outcomes

Measure	Description	Time Frame
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.	Method assessment : Beck depression inventory (BDI)	2 years
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Younes KERROUMI, MD	Contact	(+33) 1 44 64 33 84		ykerroumi@hopital-dcss.org

Overall Officials

Name	Affiliation	Role
Simon MARMOR, MD	Groupe Hospitalier Diaconesses Croix Saint-Simon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Diaconesses Croix saint Simon	Recruiting	Paris		75020	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided