Trials / Completed
CompletedNCT01963520
Prosthetic Hip Infections: Prospective Study
Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 347 (actual)
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2002-08-02
- Primary completion
- 2010-03-01
- Completion
- 2015-09-10
- First posted
- 2013-10-16
- Last updated
- 2018-02-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01963520. Inclusion in this directory is not an endorsement.