Clinical trial NCT01963520: Prosthetic Hip Infections: Prospective Study
Official title: Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Prosthesis Infection
Keywords: Hip prosthesis infection
Reinfection
Excision-synovectomy
One stage/two stage revision
Antibiotherapy
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip arthroplasty infection who underwent surgery and received antibiotic therapy in a specialized French orthopaedic center for bone and joint infection.

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

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

Primary outcomes:
measure: Incidence of reinfection (relapse and new infection)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence and causes of mechanical revision
timeFrame: 2 years
measure: Incidence and causes of death: infection or treatment related death, unrelated death
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Diaconesses Croix Saint-Simon Hospital Group
Study officials:
affiliation: Diaconesses Croix Saint-Simon Hospital Group, Paris, France
name: Valerie ZELLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.