Hip Prosthesis InfectionPHIPSNCT01963520
Prosthetic Hip Infections: Prospective Study
An observational study of Hip Prosthesis Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis Infection
- How many people
- 347 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2002to 10 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Prolonged suppressive antibiotic therapy
- No surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
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).
Read the 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
- Hip Prosthesis Infection
- Keywords
- Hip prosthesis infection, Reinfection, Excision-synovectomy, One stage/two stage revision, Antibiotherapy
- Medical subject headings
- Reinfection
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Incidence and causes of mechanical revision
Measured: 2 years
Incidence and causes of death: infection or treatment related death, unrelated death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study start2 Aug 2002
- Primary completionMar 2010
- Study completion10 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Prosthesis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Valerie ZELLER, MD, Principal investigator, Diaconesses Croix Saint-Simon Hospital Group, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963520
- Sponsor's protocol ID
- GHDCSS-01
- Acronym
- PHIPS
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8609130
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
- ClinicalTrials.gov ID
- NCT01963520
- Acronym / sponsor ID
- PHIPS / GHDCSS-01
- Conditions
- Hip Prosthesis Infection
- Keywords
- Hip prosthesis infection, Reinfection, Excision-synovectomy, One stage/two stage revision, Antibiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 2 Aug 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- 10 Sep 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Prolonged suppressive antibiotic therapy
- No surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Incidence and causes of mechanical revision
Time frame: 2 years
Incidence and causes of death: infection or treatment related death, unrelated death
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Results publication: PubMed 8609130Tsukayama 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie ZELLER, MD principal investigator
Diaconesses Croix Saint-Simon Hospital Group, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Prosthesis Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reinfection (relapse and new infection) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.