- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05367726
The Contributions of the Multidisciplinary Management of Prosthesis Knee Infections in a Reference Center: A Retrospective Study About 52 Cases.Skin Coverage in a Reference Center: A Retrospective Study About 52 Cases
May 5, 2022 updated by: Hospices Civils de Lyon
The Contributions of the Multidisciplinary Management of TKA Infections in a Reference Center: A Retrospective Study About 52 Cases.
Acute and chronic infection of knee joint prosthesis can have several outcomes, the most feared of which is trans-femoral amputation.
In order to save the limb while maintaining function, the management of these infections involves several specialists.
Orthopedic surgeons are on the front line for carrying out bacteriological samples as well as for changing the material when necessary.
The infectiologists coordinate this care by supervising each of the interventions by an antibiotic therapy adapted to the germs and by ensuring the occurrence of adverse events related to the treatment.
Plastic surgeons intervene when the skin cover of the knee is deemed to be precarious or when there is an identified loss of substance that could affect the prognosis of the prosthesis.
The main objective of our study is to evaluate the success rate of skin coverage and functional recovery for patients cured of their infection.
The secondary objective is the identification of risk factors for skin coverage in this population.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69004
- Hospices Civils de Lyon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a prosthesis knee infection infection whose management requires skin covering plastic surgery
Description
Inclusion Criteria:
- Patients with a prosthesis knee infection whose management requires skin covering plastic surgery
- Surgical procedures performed at the Croix Rousse Hospital
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients having had skin coverage of the knee
patients having had skin coverage of the knee after or at the same time than an orthopedic surgery to treat a knee prosthesis infection
|
the cutaneous cover is not always optimal to protect the prosthesis, an act of reconstructive plastic surgery is then necessary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of patients with prosthesis knee infection requiring skin coverage
Time Frame: 2011-2021
|
proportion of patients with prosthesis knee infection requiring skin coverage amaong all prosthesis knee infection
|
2011-2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
description of the population at risk of coverage after prosthesis knee infection
Time Frame: 2011-2021
|
rate of failure
|
2011-2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2022
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 10, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 776
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.