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Clinical Trials/NCT01963520
NCT01963520
Completed
N/A

Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years

Groupe Hospitalier Diaconesses Croix Saint-Simon1 site in 1 country347 target enrollmentAugust 2, 2002

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Prosthesis Infection
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Enrollment
347
Locations
1
Primary Endpoint
Incidence of reinfection (relapse and new infection)
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2, 2002
End Date
September 10, 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Responsible Party
Principal Investigator
Principal Investigator

Dr Valerie ZELLER

Investigator coordinator

Groupe Hospitalier Diaconesses Croix Saint-Simon

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of reinfection (relapse and new infection)

Time Frame: 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 Outcomes

  • Incidence and causes of mechanical revision(2 years)
  • Incidence and causes of death: infection or treatment related death, unrelated death(2 years)

Study Sites (1)

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