Prosthetic Hip Infections: Prospective Study

Completed

• Conditions: Hip Prosthesis Infection

• Registration Number: NCT01963520
• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

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).

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

Study Timeline

• Study Start: 2002-08-02
• Primary Completion: 2010-03
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Completion: 2015-09-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

• Patients with hip arthroplasty infection
• Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection
• Antibiotic therapy
• Signed informed consent

Exclusion Criteria

• Prolonged suppressive antibiotic therapy
• No surgical treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of reinfection (relapse and new infection)	2 years	The aim of this study was to prospectively determine the incidence of reinfection in patients with prosthetic hip infection after two years of follow up.

Secondary Outcome Measures

Name	Time	Method
Incidence and causes of mechanical revision	2 years
Incidence and causes of death: infection or treatment related death, unrelated death	2 years

Trial Locations

Locations (1)

Diaconesses Croix Saint-Simon Hospital Group; 🇫🇷 Paris, France