Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-04 @ 12:12 AM
Study NCT ID:
NCT01963520
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthetic Hip Infections: Prospective Study
Sponsor:
Groupe Hospitalier Diaconesses Croix Saint-Simon
Organization:
Study Overview
Official Title:
Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHIPS
Brief Summary:
Data from large prospective cohort studies of prosthetic joint infections are lacking.
Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.
Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).
Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.
Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).
Detailed Description:
Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population
* all patients who consented to participate in the study with prosthetic hip infections treated by:
* debridement-synovectomy for acute infection or with one-stage or two-stage
* exchange arthroplasty or resection arthroplasty for chronic infection
* antibiotic therapy
Outcome:
* Follow-up: minimum of 2 years
* Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths
* all patients who consented to participate in the study with prosthetic hip infections treated by:
* debridement-synovectomy for acute infection or with one-stage or two-stage
* exchange arthroplasty or resection arthroplasty for chronic infection
* antibiotic therapy
Outcome:
* Follow-up: minimum of 2 years
* Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: