Unexpected Positive Cultures in Rotator Cuff Revision Surgery
ConditionRotator Cuff Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- This study is with minimal risk and minimal constraints due to the addition of questionnaires
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov