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NCT Number: NCT06257979

Unexpected Positive Cultures in Rotator Cuff Revision Surgery

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.

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Key information

Conditions

Rotator Cuff Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé La Châtaigneraie ELSAN, Beaumont, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

In this study, the specific procedures compared to routine care are :

  • Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research.
  • The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis.
  • Antibiotic treatment cannot be prescribed immediately after the surgery 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.

Other names: Microbiological analysis of samples collected from operated patients: in the presence of UPC, it does not influence the postoperative course, No antibiotics are prescribed during the first month after the operation.

Primary outcomes

  1. 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.

    Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention

    Compare the functional recovery (Yes/No), at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results using the Constant Score.

  2. Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff

    Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention

    Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.

  3. Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff

    Time frame: up to one year after the re-intervention

    Compare the 2 groups on the occurrence of post-operative complications (Yes/No), after iterative repair of non-healing of the rotator cuff and list them

  4. Compare the 2 groups on the patient's other functional scores

    Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention

    Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries

  5. Describe the pathogenic germs found in the positive cultures

    Time frame: at Month 1 after the re-intervention

    List of pathogenic germs found in the positive samples

Secondary outcomes

  1. Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing

    Time frame: at one year after the re-intervention

    The quality of the repair was assessed using an MRI and the Sugaya classification (French version):

    Type 1: Normal thickness and echostructure of the rotator cuff. Type 2: Normal thickness and heterogeneous echostructure. Type 3: Thinning without discontinuity. Type 4: Moderate discontinuity. Type 5: Frank discontinuity.

  2. Occurrence of complications during the first post-operative year

    Time frame: up to one year after the re-intervention

    List of of complications during the first post-operative year

  3. Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)

    Time frame: at one year after the re-intervention

    ASES score can be viewed as a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.

  4. Functional scores at one year: Subjective Shoulder Value (SSV)

    Time frame: at one year after the re-intervention

    SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.

  5. Pathogenic bacteria detected in the group of patients with positive results

    Time frame: at Month 1 after the re-intervention

    List of pathogenic bacteria detected in the group of patients with positive results

Study contacts

Contact information is provided by the study sponsor or research team.

Albatoul ZAKARIA, PhD

CONTACT

[email protected]

0033 6 49 77 17 52

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing

Acronym: POCICO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 14, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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