Prosthetic Hip Infections: Prospective Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01963520

Acronym

PHIPS

Enrollment

347

Registered

2013-10-16

Start date

2002-08-02

Completion date

2015-09-10

Last updated

2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Prosthesis Infection

Keywords

Hip prosthesis infection, Reinfection, Excision-synovectomy, One stage/two stage revision, Antibiotherapy

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results