Clinical trial NCT06257979: Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Official title: Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Repair
Keywords: Unexpected Positive Cultures (UPC)
Revision cuff repair surgery (RCR)
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study procedure involves a re-intervention of the rotator cuff, which is conducted for the patients in accordance with standard practice. The patient undergoes local and/or general anesthesia, along with intravenous or oral antibiotic prophylaxis.

During the intervention, the surgeon collects the sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product) used during the re-intervention. These elements usually discarded, are collected for the bacteriological analysis.

Antibiotic treatment cannot be prescribed immediately and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results.
timeFrame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
measure: Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff
timeFrame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
measure: Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff
timeFrame: up to one year after the re-intervention
measure: Compare the 2 groups on the patient's other functional scores
timeFrame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
measure: Describe the pathogenic germs found in the positive cultures
timeFrame: at Month 1 after the re-intervention
Secondary outcomes:
measure: Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing
timeFrame: at one year after the re-intervention
measure: Occurrence of complications during the first post-operative year
timeFrame: up to one year after the re-intervention
measure: Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)
timeFrame: at one year after the re-intervention
measure: Functional scores at one year: Subjective Shoulder Value (SSV)
timeFrame: at one year after the re-intervention
measure: Pathogenic bacteria detected in the group of patients with positive results
timeFrame: at Month 1 after the re-intervention
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Hôpital privé La Châtaigneraie ELSAN
city: Caen
country: France
facility: Hôpital privé Saint-Martin
city: Essey-lès-Nancy
country: France
facility: Clinique Louis Pasteur
city: Lyon
country: France
facility: Santy-Lyon-Ramsay
city: Muret
country: France
facility: Clinique d'occitanie ELSAN
city: Nice
country: France
facility: ICR-Kantys
city: Saint-Herblain
country: France
facility: Santé Atlantique ELSAN
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
Study officials:
affiliation: Clinique de l'Orangerie-Strasbourg
name: Maxime ANTONI, MD
role: STUDY_DIRECTOR
References:
citation: Zhao J, Luo M, Pan J, Liang G, Feng W, Zeng L, Yang W, Liu J. Risk factors affecting rotator cuff retear after arthroscopic repair: a meta-analysis and systematic review. J Shoulder Elbow Surg. 2021 Nov;30(11):2660-2670. doi: 10.1016/j.jse.2021.05.010. Epub 2021 Jun 2.
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