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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Other | Operated patients with positive results for their pre-operative microbiological samples. |
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| Control group | Other | Operated patients with negative results for their pre-operative microbiological samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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 | 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 | at Month 1 after the re-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albatoul ZAKARIA, PhD | Contact | 0033 6 49 77 17 52 | zakaria@elsan.care |
| Name | Affiliation | Role |
|---|---|---|
| Maxime ANTONI, MD | Clinique de l'Orangerie-Strasbourg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé La Châtaigneraie ELSAN | Not yet recruiting | Beaumont | 63110 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34089878 | Background | 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. | |
| 35671929 | Background | Azar M, Van der Meijden O, Pireau N, Chelli M, Gonzalez JF, Boileau P. Arthroscopic revision cuff repair: do tendons have a second chance to heal? J Shoulder Elbow Surg. 2022 Dec;31(12):2521-2531. doi: 10.1016/j.jse.2022.04.024. Epub 2022 Jun 6. |
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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.
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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.
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| 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 | 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. | 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%. | 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 | at Month 1 after the re-intervention |
| Hôpital privé Saint-Martin | Not yet recruiting | Caen | 14050 | France |
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| Clinique Louis Pasteur | Not yet recruiting | Essey-lès-Nancy | 54270 | France |
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| Santy-Lyon-Ramsay | Not yet recruiting | Lyon | 69008 | France |
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| Clinique d'occitanie ELSAN | Not yet recruiting | Muret | 31600 | France |
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| ICR-Kantys | Not yet recruiting | Nice | 06000 | France |
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| Santé Atlantique ELSAN | Not yet recruiting | Saint-Herblain | 44800 | France |
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| Clinique de l'Orangerie | Recruiting | Strasbourg | France |
|
| 28507783 | Background | Bonnevialle N, Dauzeres F, Toulemonde J, Elia F, Laffosse JM, Mansat P. Periprosthetic shoulder infection: an overview. EFORT Open Rev. 2017 Apr 27;2(4):104-109. doi: 10.1302/2058-5241.2.160023. eCollection 2017 Apr. |
| 35598759 | Background | Neufeld ME, Lanting BA, Shehata M, Naudie DDR, McCalden RW, Teeter MG, Vasarhelyi EM. The Prevalence and Outcomes of Unexpected Positive Intraoperative Cultures in Presumed Aseptic Revision Knee Arthroplasty. J Arthroplasty. 2022 Nov;37(11):2262-2271. doi: 10.1016/j.arth.2022.05.036. Epub 2022 May 19. |
| 33548396 | Background | Falstie-Jensen T, Lange J, Daugaard H, Sorensen AKB, Ovesen J, Soballe K; ROSA Study Group. Unexpected positive cultures after revision shoulder arthroplasty: does it affect outcome? J Shoulder Elbow Surg. 2021 Jun;30(6):1299-1308. doi: 10.1016/j.jse.2020.12.014. Epub 2021 Feb 3. |
| 35513254 | Background | Hodakowski AJ, Cohn MR, Mehta N, Menendez ME, McCormick JR, Garrigues GE. An evidence-based approach to managing unexpected positive cultures in shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Oct;31(10):2176-2186. doi: 10.1016/j.jse.2022.03.019. Epub 2022 May 2. |
| 3791738 | Background | Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. |
| 16325080 | Background | Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011. |
| 18311752 | Background | Angst F, Goldhahn J, Drerup S, Aeschlimann A, Schwyzer HK, Simmen BR. Responsiveness of six outcome assessment instruments in total shoulder arthroplasty. Arthritis Rheum. 2008 Mar 15;59(3):391-8. doi: 10.1002/art.23318. |
| 18061114 | Background | Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123. |