Unexpected Positive Cultures in Rotator Cuff Revision Surgery

NCT06257979 | Recruiting DMC

• 1 other identifier: 2023-A02042-43
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 8

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.

Conditions

Rotator Cuff Repair

Keywords

Unexpected Positive Cultures (UPC); Revision cuff repair surgery (RCR)

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing

  at one year after the re-intervention

• Occurrence 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)

  at one year after the re-intervention

• Functional scores at one year: Subjective Shoulder Value (SSV)

  at one year after the re-intervention

• Pathogenic bacteria detected in the group of patients with positive results

  at Month 1 after the re-intervention

Study Arms (2)

Experimental group

OTHER

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

Control group

OTHER

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

Interventions

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 : * 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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participant in another research
• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (8)

Hôpital privé La Châtaigneraie ELSAN

Beaumont, 63110, France

NOT YET RECRUITING

Hôpital privé Saint-Martin

Caen, 14050, France

NOT YET RECRUITING

Clinique Louis Pasteur

Essey-lès-Nancy, 54270, France

NOT YET RECRUITING

Santy-Lyon-Ramsay

Lyon, 69008, France

NOT YET RECRUITING

Clinique d'occitanie ELSAN

Muret, 31600, France

NOT YET RECRUITING

ICR-Kantys

Nice, 06000, France

NOT YET RECRUITING

Santé Atlantique ELSAN

Saint-Herblain, 44800, France

NOT YET RECRUITING

Clinique de l'Orangerie

Strasbourg, France

RECRUITING

Related Publications (10)

• 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 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.

  PMID: 35671929 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.

  PMID: 28507783 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.

  PMID: 35598759 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.

  PMID: 33548396 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.

  PMID: 35513254 BACKGROUND

• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

  PMID: 3791738 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.

  PMID: 16325080 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.

  PMID: 18311752 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.

  PMID: 18061114 BACKGROUND

Study Officials

• Maxime ANTONI, MD

  Clinique de l'Orangerie-Strasbourg

  STUDY DIRECTOR

Central Study Contacts

Albatoul ZAKARIA, PhD

CONTACT

0033 6 49 77 17 52; zakaria@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 14, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)