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Completed

NCT Number: NCT01963520

Prosthetic Hip Infections: Prospective Study

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).

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Key information

Conditions

Hip Prosthesis Infection Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Reinfection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diaconesses Croix Saint-Simon Hospital Group

Paris, 75020, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of reinfection (relapse and new infection)

    Time frame: 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 outcomes

  1. Incidence and causes of mechanical revision

    Time frame: 2 years

  2. Incidence and causes of death: infection or treatment related death, unrelated death

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Official study title

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

Acronym: PHIPS

Important dates

Study start
2002
Primary completion
2010
Study completion
2015
First posted
Oct 16, 2013
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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