Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Rotator Cuff Repair Clinical Trial

— POCICO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257979
• Other study ID #: 2023-A02042-43
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: March 15, 2028

Study information

• Verified date: June 2024
• Source: Elsan
• Contact: Albatoul ZAKARIA, PhD
• Phone: 0033 6 49 77 17 52
• Email: zakaria[@]elsan.care
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 15, 2028
• Est. primary completion date: February 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Repair

Intervention

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 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	at one year after the re-intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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