Shoulder Instability Subluxation BilateralCISALNCT05658211
Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.
An observational study of Shoulder Instability Subluxation Bilateral, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This is a multicenter study of data from the medical records of patients who underwent shoulder stabilization surgery and who underwent a normally scheduled evaluation as part of their postoperative follow-up six months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Instability Subluxation Bilateral
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with no history of previous shoulder surgery or suspicion of underlying infection, operated on in the first instance for anterior shoulder instability by the conventional Latarjet technique (open surgery).
Who may be able to join
- Patient 18 years of age or older, who has been informed of the research
- Patient who has undergone a first-line Latarjet operation
- Patient with three cultures performed on the coracoid bone blocks
- Patient regularly followed since the operation and for whom all data are available during the six-month follow-up visit.
Who cannot join
- Previous open shoulder surgery
- Associated rotator cuff injury requiring repair
- Clinical signs of preoperative infection
- Patient under court protection, guardianship or curatorship
- Patient who has indicated his or her opposition to the use of his or her medical data (by filling out and returning the non-opposition form that will be sent to him or her).
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter study of data from the medical records of patients who underwent shoulder stabilization surgery and who underwent a normally scheduled evaluation as part of their postoperative follow-up six months after surgery.
Read the detailed description
Infection is a major cause of failure in shoulder arthroplasty and must be systematically sought at the time of revision, even if this is motivated by other complications (loosening, instability, periprosthetic fracture).
These cultures, performed in patients without clinical suspicion of infection, reveal, in 25 to 60% of cases, the presence of germs of cutaneous origin which, although generally considered to be non-virulent, continue to be debated as to their clinical significance and their implication in the failure of shoulder arthroplasty. Among these germs, propionibacterium acnes, staphylococcus epidermidis or coagulasenegative Staphylococcus are the most frequently identified.
The origin of these germs is still debated. Cultures of deep synovial fluid or tissues from patients receiving a first-line shoulder prosthesis show the presence of Cutibacterium acnes in 9% to 41% of cases despite preoperative antibiotic prophylaxis. These infections could be the consequence of contamination by a commensal germ during surgical exposure. Other authors consider them as an etiological factor in the development of shoulder arthritis. They would be more frequent in young subjects and male subjects.
The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.
It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.
The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.
It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive culture
The primary endpoint, based on the culture result, is the number of patients with at least one positive culture
Measured: Month 6
Secondary outcomes (3)
Walch-Duplay Questionnaire
The Walch questionnaire includes a descriptive part (type and level of sport practiced, dominant score) and an evaluation scale of subjective and objective data (stability, pain, recovery of sport level, mobility) to assess the clinical result of the shoulder stabilization. The score ranges from 0 to 100. The result is considered excellent for a score of 91 to 100 points, good for 76 to 90 points, average for 51 to 75 points, and poor for a score of 50 points or less.
Measured: Month 6
Constant score
The Constant and Murley score explores several domains: pain, activity, strength and mobility.
The total score varies from 0 to 100 points, 100 points corresponding to a normal shoulder and 0 to a totally deficient shoulder.
Measured: Month 6
Bacteriological criterion
Nature of germs identified in culture
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Instability Subluxation BilateralStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658211
- Sponsor's protocol ID
- COS-RGDS-2021-06-014
- Acronym
- CISAL
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.
- ClinicalTrials.gov ID
- NCT05658211
- Acronym / sponsor ID
- CISAL / COS-RGDS-2021-06-014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter study of data from the medical records of patients who underwent shoulder stabilization surgery and who underwent a normally scheduled evaluation as part of their postoperative follow-up six months after surgery.
Detailed description
Infection is a major cause of failure in shoulder arthroplasty and must be systematically sought at the time of revision, even if this is motivated by other complications (loosening, instability, periprosthetic fracture).
These cultures, performed in patients without clinical suspicion of infection, reveal, in 25 to 60% of cases, the presence of germs of cutaneous origin which, although generally considered to be non-virulent, continue to be debated as to their clinical significance and their implication in the failure of shoulder arthroplasty. Among these germs, propionibacterium acnes, staphylococcus epidermidis or coagulasenegative Staphylococcus are the most frequently identified.
The origin of these germs is still debated. Cultures of deep synovial fluid or tissues from patients receiving a first-line shoulder prosthesis show the presence of Cutibacterium acnes in 9% to 41% of cases despite preoperative antibiotic prophylaxis. These infections could be the consequence of contamination by a commensal germ during surgical exposure. Other authors consider them as an etiological factor in the development of shoulder arthritis. They would be more frequent in young subjects and male subjects.
The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.
It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.
The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.
It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with no history of previous shoulder surgery or suspicion of underlying infection, operated on in the first instance for anterior shoulder instability by the conventional Latarjet technique (open surgery).
Key inclusion criteria (4 listed)
- Patient 18 years of age or older, who has been informed of the research
- Patient who has undergone a first-line Latarjet operation
- Patient with three cultures performed on the coracoid bone blocks
- Patient regularly followed since the operation and for whom all data are available during the six-month follow-up visit.
Key exclusion criteria (5 listed)
- Previous open shoulder surgery
- Associated rotator cuff injury requiring repair
- Clinical signs of preoperative infection
- Patient under court protection, guardianship or curatorship
- Patient who has indicated his or her opposition to the use of his or her medical data (by filling out and returning the non-opposition form that will be sent to him or her).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with positive culture
Time frame: Month 6
The primary endpoint, based on the culture result, is the number of patients with at least one positive culture
3 secondary outcomes
Walch-Duplay Questionnaire
Time frame: Month 6
Constant score
Time frame: Month 6
Bacteriological criterion
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Instability Subluxation Bilateral, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive culture (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.