Lyon PJI Retrospective Cohort Study

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04722926
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 25.7
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs.

This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

Condition or Disease	Intervention/Treatment	Phase
Bone and Joint Infection	Other: PJI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Lyon Prosthetic Joint Infection Retrospective Cohort Study
• Actual Study Start Date: Jan 10, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
PJI Patients having had a PJI	Other: PJI; patients having had a PJI managed at the CRIOAc Lyon, with or without relapse

Outcome Measures

Primary Outcome Measures

1. rate of PJI [between 2018 and 2020]

   proportion of PJI among all BJI

2. Description of PJI [between 2018 and 2020]

   acute/chronic

3. Description of type of prosthesis PJI [between 2018 and 2020]

   number of prosthesis

4. Description of patients having had a PJI [between 2018 and 2020]

   type of patients: age

5. Description of comorbidities of patients having had a PJI [between 2018 and 2020]

   type of comorbidities..

6. rate of bacteria [between 2018 and 2020]

   epidemiologic description of PJI

7. description of antibiotic used [between 2018 and 2020]

   type of antibiotic : name

8. description of antibiotic treatment [between 2018 and 2020]

   duration of antibiotic treatment

9. description of surgical treatment [between 2018 and 2020]

   type of surgery: 1-step exchange, 2- step exchange, DAIR

Secondary Outcome Measures

1. rate of failure [between 2018 and 2020]

   proportion of patients having a failure

2. description of the failure [between 2018 and 2020]

   type of failure : persistence or surinfection and management of failure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• patients having had a PJI between 2018 and 2020

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04722926
• Other Study ID Numbers: 268
• First Posted: Jan 25, 2021
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: prosthesis joint infection; relapse
• Additional relevant MeSH terms: Infections; Arthritis, Infectious

Study Results

No Results Posted as of Jan 20, 2022