Prosthetic Hip Infections: Prospective Study

NCT ID: NCT01963520

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-02

Study Completion Date

2015-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Prosthesis Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Groupe Hospitalier Diaconesses Croix Saint-Simon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Valerie ZELLER

Investigator coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valerie ZELLER, MD

Role: PRINCIPAL_INVESTIGATOR

Diaconesses Croix Saint-Simon Hospital Group, Paris, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diaconesses Croix Saint-Simon Hospital Group

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 8609130 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GHDCSS-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IP-coated Revision Hip Implants
NCT06737809 RECRUITING NA
AvenirĀ® Cemented Hip Stem - PMCF
NCT03396224 ACTIVE_NOT_RECRUITING