Actively Recruiting
Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Led by Elsan · Updated on 2024-06-18
132
Participants Needed
8
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, male or female, aged 18 or over
- Patient requiring re-intervention for rotator cuff revision surgery for non-healing of the same tendons after a first intervention (delay <2 years)
- Patient requiring arthroscopy
- Patient having had an 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 will not qualify if you...
- 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 cuff 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
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Hôpital privé La Châtaigneraie ELSAN
Beaumont, France, 63110
Not Yet Recruiting
2
Hôpital privé Saint-Martin
Caen, France, 14050
Not Yet Recruiting
3
Clinique Louis Pasteur
Essey-lès-Nancy, France, 54270
Not Yet Recruiting
4
Santy-Lyon-Ramsay
Lyon, France, 69008
Not Yet Recruiting
5
Clinique d'occitanie ELSAN
Muret, France, 31600
Not Yet Recruiting
6
ICR-Kantys
Nice, France, 06000
Not Yet Recruiting
7
Santé Atlantique ELSAN
Saint-Herblain, France, 44800
Not Yet Recruiting
8
Clinique de l'Orangerie
Strasbourg, France
Actively Recruiting
Research Team
A
Albatoul ZAKARIA, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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