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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05367726
Other study ID # 776
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date September 1, 2022

Study information

Verified date May 2022
Source Hospices Civils de Lyon
Contact Tristan Ferry, Md,PhD
Phone 04 26 73 29 38
Email tristan.ferry@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date September 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
patients having had skin coverage of the knee
the cutaneous cover is not always optimal to protect the prosthesis, an act of reconstructive plastic surgery is then necessary

Locations

Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2011-2021
Secondary description of the population at risk of coverage after prosthesis knee infection rate of failure 2011-2021
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