Examining the impact of unexpected positive cultures in rotator cuff revision surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the effects of unexpected positive cultures (UPC) found during rotator cuff revision surgeries. It aims to determine whether the presence of these cultures, in the absence of clinical infection symptoms, affects clinical outcomes and tendon healing rates. The study will involve collecting bacteriological samples from patients undergoing re-intervention for rotator cuff repairs and comparing results from those with positive and negative cultures. The findings could help clarify the management of UPC and inform antibiotic therapy guidelines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient, male or female, aged 18 or over
* Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay \<2 years)
* Patient requiring arthroscopy
* Patient having had realized a 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

Exclusion Criteria:

* 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 Ruff 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

Where it's running

• Clinique de l'Orangerie
  Strasbourg, France Recruiting
• Hôpital privé La Châtaigneraie ELSAN
  Beaumont, France Not yet recruiting
• Hôpital privé Saint-Martin
  Caen, France Not yet recruiting
• Clinique Louis Pasteur
  Essey-lès-Nancy, France Not yet recruiting
• Santy-Lyon-Ramsay
  Lyon, France Not yet recruiting
• Clinique d'occitanie ELSAN
  Muret, France Not yet recruiting

Study contacts

• Study coordinator: Albatoul ZAKARIA, PhD
• Email: zakaria@elsan.care
• Phone: 0033 6 49 77 17 52

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.