Unexpected Positive Cultures in Rotator Cuff Revision Surgery
ConditionRotator Cuff Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
This study is with minimal risk and minimal constraints due to the addition of questionnaires
Other interventionIn 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.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Experimental groupOther 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
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.
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-intervention2
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-intervention3
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-intervention4
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-interventionSecondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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 Source ClinicalTrials.gov