Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Official title

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

Overview

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

• 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 disca

Primary outcome measures

• 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 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 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 patient's other functional scores [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 [Time frame: at Month 1 after the re-intervention]

Secondary outcome measures (5)

• Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing [Time frame: at one year after the re-intervention]
• Occurrence 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) [Time frame: at one year after the re-intervention]
• Functional scores at one year: Subjective Shoulder Value (SSV) [Time frame: at one year after the re-intervention]
• Pathogenic bacteria detected in the group of patients with positive results [Time frame: at Month 1 after the re-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

France · 8 centers

• Hôpital privé La Châtaigneraie ELSAN — Beaumont
• Hôpital privé Saint-Martin — Caen
• Clinique Louis Pasteur — Essey-lès-Nancy
• Santy-Lyon-Ramsay — Lyon
• Clinique d'occitanie ELSAN — Muret
• ICR-Kantys — Nice
• Santé Atlantique ELSAN — Saint-Herblain
• Clinique de l'Orangerie — Strasbourg

Publications

• 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. PMID 34089878
• 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. PMID 35671929
• 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. PMID 28507783
• 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. PMID 35598759
• 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. PMID 33548396
• 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. PMID 35513254
• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. PMID 3791738
• 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. PMID 16325080

Identifiers

NCT: NCT06257979 · 2023-A02042-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗