An interventional study of This study is with minimal risk and minimal constraints due to the addition of questionnaires in Rotator Cuff Repair, sponsored by Elsan. Recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Elsan · Not applicable, Interventional, and Other
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.
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.
Elsan is the lead sponsor of 66 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Operated patients with positive results for their pre-operative microbiological samples.
Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires
Operated patients with negative results for their pre-operative microbiological samples.
Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires
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.
Also known as: 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.
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.
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.
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff
Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff
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
Time frame: up to one year after the re-intervention
Compare the 2 groups on the patient's other functional scores
Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries
Time frame: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Describe the pathogenic germs found in the positive cultures
List of pathogenic germs found in the positive samples
Time frame: at Month 1 after the re-intervention
Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing
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.
Time frame: at one year after the re-intervention
Occurrence of complications during the first post-operative year
List of of complications during the first post-operative year
Time frame: up to one year after the re-intervention
Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)
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.
Time frame: at one year after the re-intervention
Functional scores at one year: Subjective Shoulder Value (SSV)
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%.
Time frame: at one year after the re-intervention
Pathogenic bacteria detected in the group of patients with positive results
List of pathogenic bacteria detected in the group of patients with positive results
Time frame: at Month 1 after the re-intervention
Plan to share: No
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