NCT05367726

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

May 5, 2022

Last Update Submit

May 5, 2022

Conditions

Keywords

knee joint prosthesisFlapSkin Graft

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • description of the population at risk of coverage after prosthesis knee infection

    2011-2021

Study Arms (1)

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

Other: patients having had skin coverage of the knee

Interventions

the cutaneous cover is not always optimal to protect the prosthesis, an act of reconstructive plastic surgery is then necessary

patients having had skin coverage of the knee

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a prosthesis knee infection infection whose management requires skin covering plastic surgery

You may qualify if:

  • Patients with a prosthesis knee infection whose management requires skin covering plastic surgery
  • Surgical procedures performed at the Croix Rousse Hospital

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

Central Study Contacts

Tristan Ferry, Md,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

May 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations