Unexpected Positive Cultures in Rotator Cuff Revision Surgery (POCICO)

Elsan

Status: Enrolling

Conditions: Rotator Cuff Repair

Treatments: Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06257979

2023-A02042-43

Details and patient eligibility

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.

Full description

Rotator cuff injuries are a common pathology with a 30% prevalence in the general population. If rotator cuff repair fails, patients often experience persistent pain, and bacteria can be detected during the revision period in approximately 30% of cases, even in the absence of septic symptoms. This type of infection, referred to as low-level infection, occurs in around 5% of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention.

Bacteriological samples are routinely collected during revisions, especially for prostheses. The appropriate course of action in cases where these samples test positive, yet there are no signs of infection, remains to be clarified. Notably, administering antibiotics in response to unexpected positive cultures (UPC) during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates.

In the context of rotator cuff re-interventions, the impact of UPC has not been well-documented. The management of UPC, particularly regarding antibiotic therapy, has not been thoroughly studied and is not currently recommended. Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Experimental group

Other group

Description:

Operated patients with positive results for their pre-operative microbiological samples.

Treatment:

Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires

Control group

Other group

Description:

Operated patients with negative results for their pre-operative microbiological samples.

Treatment:

Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires