Prosthetic Hip Infections: Prospective Study
PHIPS
Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
1 other identifier
observational
347
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2015
CompletedFebruary 14, 2018
February 1, 2018
7.6 years
September 26, 2013
February 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of reinfection (relapse and new infection)
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.
2 years
Secondary Outcomes (2)
Incidence and causes of mechanical revision
2 years
Incidence and causes of death: infection or treatment related death, unrelated death
2 years
Eligibility Criteria
Patients with hip arthroplasty infection who underwent surgery and received antibiotic therapy in a specialized French orthopaedic center for bone and joint infection.
You may qualify if:
- 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
You may not qualify if:
- Prolonged suppressive antibiotic therapy
- No surgical treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diaconesses Croix Saint-Simon Hospital Group
Paris, 75020, France
Related Publications (1)
Tsukayama DT, Estrada R, Gustilo RB. Infection after total hip arthroplasty. A study of the treatment of one hundred and six infections. J Bone Joint Surg Am. 1996 Apr;78(4):512-23. doi: 10.2106/00004623-199604000-00005.
PMID: 8609130RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie ZELLER, MD
Diaconesses Croix Saint-Simon Hospital Group, Paris, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator coordinator
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 16, 2013
Study Start
August 2, 2002
Primary Completion
March 1, 2010
Study Completion
September 10, 2015
Last Updated
February 14, 2018
Record last verified: 2018-02