Knee Joint Prosthesis InfectionNCT05367726
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
An observational study of Knee Joint Prosthesis Infection and Flap Necrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Joint Prosthesis Infection, Flap Necrosis, Skin Graft Complications
- What is being tested?
- patients having had skin coverage of the knee
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 Sep 2022
- 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
- Adult, Older adult
Study population: Patients with a prosthesis knee infection infection whose management requires skin covering plastic surgery
Who may be able to join
- Patients with a prosthesis knee infection whose management requires skin covering plastic surgery
- Surgical procedures performed at the Croix Rousse Hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA, 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr
About this study
Official title: 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.
- Being tested
- patients having had skin coverage of the knee
- Keywords
- knee joint prosthesis, Flap, Skin Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had skin coverage of the kneeOther
the cutaneous cover is not always optimal to protect the prosthesis, an act of reconstructive plastic surgery is then necessary
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: patients having had skin coverage of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients with prosthesis knee infection requiring skin coverage
proportion of patients with prosthesis knee infection requiring skin coverage amaong all prosthesis knee infection
Measured: 2011-2021
Secondary outcomes (1)
description of the population at risk of coverage after prosthesis knee infection
rate of failure
Measured: 2011-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Joint Prosthesis InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367726
- Sponsor's protocol ID
- 776
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contributions of the Multidisciplinary Management of TKA Infections in a Reference Center: A Retrospective Study About 52 Cases.
- ClinicalTrials.gov ID
- NCT05367726
- Acronym / sponsor ID
- 776
- Keywords
- knee joint prosthesis, Flap, Skin Graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 10 May 2022 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had skin coverage of the knee | – | Other: patients having had skin coverage of the kneepatients having had skin coverage of the knee after or at the same time than an orthopedic surgery to treat a knee prosthesis infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a prosthesis knee infection infection whose management requires skin covering plastic surgery
Key inclusion criteria (2 listed)
- Patients with a prosthesis knee infection whose management requires skin covering plastic surgery
- Surgical procedures performed at the Croix Rousse Hospital
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients having had skin coverage of the kneethe cutaneous cover is not always optimal to protect the prosthesis, an act of reconstructive plastic surgery is then necessary | Other | patients having had skin coverage of the knee |
Primary outcome
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
1 secondary outcome
description of the population at risk of coverage after prosthesis knee infection
Time frame: 2011-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- website of crioac lyonLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Knee Joint Prosthesis Infection and Flap Necrosis, run by Hospices Civils de Lyon 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan Ferry, Md,PhD (04 26 73 29 38, tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients with prosthesis knee infection requiring skin coverage (time frame: 2011-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.