LatarjetDom LatNCT05150379
Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively.
An observational study of Latarjet and Shoulder Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Latarjet, Shoulder Injuries
- What is being tested?
- Different exercises with their shoulders and SI-RSI questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2021to 5 Dec 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patient and healthy volunteers between 15 and 45 years old. Patients have an operated shoulder following an injury during a sport activity.
Who may be able to join
- Patients: o patient between 15 and 45 years old
- Occurrence of the injury requiring surgery during a sports activity
- Reduced shoulder instability by the open Latarjet procedure
- Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
- Inclusion by decision of the surgeon during the visit 4 months postoperatively
- Healthy volunteers :
Show all 11Show fewer
- volunteer between 15 and 45 years old
- Practice a regular sporting activity
- Both groups:
- Patient having signed an informed consent
- Subject affiliated or beneficiary of a social security scheme
Who cannot join
- Patient group:
- Contraindication of the surgeon
- Have another pathology in the upper limbs
- Present a constitutional hyperlaxity
- Have stiffness or recurrence of dislocation of the shoulder post-surgery
- Healthy volunteers :
Show all 10Show fewer
- Medical history of upper limb pain / injury within the past 12 months
- Medical history of orthopedic surgery on the upper limbs
- Both groups:
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
About this study
Official title: Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively: Patients Operated on the Dominant Side vs. Patients Operated on the Non-dominant Side vs. Healthy Controls
The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.
- Conditions
- Latarjet, Shoulder Injuries
- Being tested
- Different exercises with their shoulders, SI-RSI questionnaire
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different exercises with their shouldersOther
- Y Balance Test
- Shoulder rotator muscle isometric maximum strength
- One handed medicine ball throw
- Modified Closed Kinetic Chain Upper Extremity Stability Test
SI-RSI questionnaireBehavioural
French version of Shoulder Instability Return-to-Sport after Injury
| Study group | Role | What they receive |
|---|---|---|
| Dominant side shoulder surgery patients | Not described Receives: Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire | |
| Patients operated on the shoulder on the non-dominant side | Not described Receives: Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire | |
| Healthy volunteers | Not described Receives: Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-STARTS composite score for each participant
Score between 0 and 21:
- 0: total functional disability
- 21: full functional ability
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start5 Dec 2021 (estimated)
- Primary completion5 Jun 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LatarjetStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150379
- Sponsor's protocol ID
- Not yet assigned
- Acronym
- Dom Lat
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rogowski I, Nove-Josserand L, Godeneche A, Colotte P, Franger G, Vigne G, Vieira TD, Blache Y, Neyton L. Functional Deficits After Open Latarjet Procedure and Dominance of the Operated Shoulder: An Analysis of 133 Patients. Am J Sports Med. 2023 Apr;51(5):1277-1285. doi: 10.1177/03635465231156181. Epub 2023 Feb 27.
PubMed 36847281
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively: Patients Operated on the Dominant Side vs. Patients Operated on the Non-dominant Side vs. Healthy Controls
- ClinicalTrials.gov ID
- NCT05150379
- Acronym / sponsor ID
- Dom Lat / Not yet assigned
- Conditions
- Latarjet, Shoulder Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 5 Dec 2021 (estimated)
- Primary completion
- 5 Jun 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dominant side shoulder surgery patients | – | Other: Different exercises with their shoulders, Behavioral: SI-RSI questionnaire |
| Patients operated on the shoulder on the non-dominant side | – | Other: Different exercises with their shoulders, Behavioral: SI-RSI questionnaire |
| Healthy volunteers | – | Other: Different exercises with their shoulders, Behavioral: SI-RSI questionnaire |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patient and healthy volunteers between 15 and 45 years old. Patients have an operated shoulder following an injury during a sport activity.
Key inclusion criteria (11 listed)
- Patients: o patient between 15 and 45 years old
- Occurrence of the injury requiring surgery during a sports activity
- Reduced shoulder instability by the open Latarjet procedure
- Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
- Inclusion by decision of the surgeon during the visit 4 months postoperatively
Key exclusion criteria (10 listed)
- Contraindication of the surgeon
- Have another pathology in the upper limbs
- Present a constitutional hyperlaxity
- Have stiffness or recurrence of dislocation of the shoulder post-surgery
- Medical history of upper limb pain / injury within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different exercises with their shoulders* Y Balance Test * Shoulder rotator muscle isometric maximum strength * One handed medicine ball throw * Modified Closed Kinetic Chain Upper Extremity Stability Test | Other | Dominant side shoulder surgery patients, Healthy volunteers, Patients operated on the shoulder on the non-dominant side |
| SI-RSI questionnaireFrench version of Shoulder Instability Return-to-Sport after Injury | Behavioural | Dominant side shoulder surgery patients, Healthy volunteers, Patients operated on the shoulder on the non-dominant side |
Primary outcome
S-STARTS composite score for each participant
Time frame: 1 hour
Score between 0 and 21: * 0: total functional disability * 21: full functional ability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 36847281Rogowski I, Nove-Josserand L, Godeneche A, Colotte P, Franger G, Vigne G, Vieira TD, Blache Y, Neyton L. Functional Deficits After Open Latarjet Procedure and Dominance of the Operated Shoulder: An Analysis of 133 Patients. Am J Sports Med. 2023 Apr;51(5):1277-1285. doi: 10.1177/03635465231156181. Epub 2023 Feb 27.
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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.
Marie-Hélène Barba contact
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 Latarjet and Shoulder Injuries, 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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-STARTS composite score for each participant (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150379, which also lists 1 linked publication.
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 9 Dec 2021.