Prosthetic Hip Infections: Prospective Study

Hip Prosthesis Infection Clinical Trial

— PHIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963520
• Other study ID #: GHDCSS-01
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: February 13, 2018
• Start date: August 2, 2002
• Est. completion date: September 10, 2015

Study information

• Verified date: February 2018
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: September 10, 2015
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hip Prosthesis Infection
• Infection

Locations

Country	Name	City	State
France	Diaconesses Croix Saint-Simon Hospital Group	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and causes of mechanical revision		2 years
Secondary	Incidence and causes of death: infection or treatment related death, unrelated death		2 years