Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06257979

Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Led by Elsan · Updated on 2024-06-18

132

Participants Needed

8

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus. A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.

CONDITIONS

Official Title

Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient, male or female, aged 18 or over
  • Patient requiring re-intervention for rotator cuff revision surgery for non-healing of the same tendons after a first intervention (delay <2 years)
  • Patient requiring arthroscopy
  • Patient having had an MRI of the shoulder in the 6 previous months
  • Affiliate participant or beneficiary of a social security scheme
  • Participant having been informed and not having objected to the use of their data
Not Eligible

You will not qualify if you...

  • Patient with at least one clinical sign of infection (fever, redness)
  • Patient with a new distant rupture on a healed cuff (> 3 years)
  • Patient with a history of shoulder surgery other than initial rotator cuff surgery
  • Patient having received antibiotic treatment in the 2 weeks preceding inclusion
  • Participant in another research
  • Participant in a period of exclusion from another research still in progress at the time of inclusion
  • Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding or parturient woman
  • Participant hospitalized without consent

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Hôpital privé La Châtaigneraie ELSAN

Beaumont, France, 63110

Not Yet Recruiting

2

Hôpital privé Saint-Martin

Caen, France, 14050

Not Yet Recruiting

3

Clinique Louis Pasteur

Essey-lès-Nancy, France, 54270

Not Yet Recruiting

4

Santy-Lyon-Ramsay

Lyon, France, 69008

Not Yet Recruiting

5

Clinique d'occitanie ELSAN

Muret, France, 31600

Not Yet Recruiting

6

ICR-Kantys

Nice, France, 06000

Not Yet Recruiting

7

Santé Atlantique ELSAN

Saint-Herblain, France, 44800

Not Yet Recruiting

8

Clinique de l'Orangerie

Strasbourg, France

Actively Recruiting

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Research Team

A

Albatoul ZAKARIA, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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