Rotator Cuff Repair
Conditions
Keywords
Unexpected Positive Cultures (UPC), Revision cuff repair surgery (RCR)
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.
Interventions
OTHERThis 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.
Sponsors
Elsan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Following the analysis of the bacteriological samples, the investigator will read the bacteriological results. These will be entered into the database. During subsequent visits, the investigator will not provide this information to the patient who will thus remain as a single blind.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe the pathogenic germs found in the positive cultures | at Month 1 after the re-intervention | List of pathogenic germs found in the positive samples |
| 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. | 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. |
| Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff | 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. |
| Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff | 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 |
| Compare the 2 groups on the patient's other functional scores | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing | 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. |
| Occurrence of complications during the first post-operative year | up to one year after the re-intervention | List of of complications during the first post-operative year |
| Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES) | 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. |
| Functional scores at one year: Subjective Shoulder Value (SSV) | 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%. |
| Pathogenic bacteria detected in the group of patients with positive results | at Month 1 after the re-intervention | List of pathogenic bacteria detected in the group of patients with positive results |
Countries
France
Contacts
Primary ContactAlbatoul ZAKARIA, PhD
Outcome results
None listed