Dislocation ShoulderMATASI-LNCT06154889
Rehabilitation by Multifactorial Approach After a Latarjet Procedure
A study testing consultations with a psychologist and Conventional reeducation in people with Dislocation Shoulder, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Dislocation Shoulder
- What is being tested?
- consultations with a psychologist and Conventional reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or recurrent traumatic anterior dislocation of the shoulder
- Indication of abutment according to Latarjet (arthroscopic or open sky)
- Age: 18-67 years
- Understanding of the French language spoken and written
- Written informed consent (in accordance with to ICH-GCP guidelines)
Who cannot join
- Posterior or multidirectional instability of the shoulder (Beighton score >5)
- Age <18 or >67 years.
- Patients with additional rotator cuff tear.
- Patients with a history of surgery on either shoulder.
- Patients with connective tissue disorders (eg Ehler-Danlos).
- Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications).
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- Patients with neurological disorders or systemic disease.
- Patients with inflammatory disease, rheumatoid arthritis or active malignancy.
- Patients previously hospitalized for shoulder pain
- Patients with upper tubercle fracture
- Patients with motor neurological deficit
- Pregnant or breastfeeding patient
- Patient protected under protective measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Générale d'Annecy
Annecy, 74000
Alexandre Coste, +336 40 98 05 51, acoste@vivalto-sante.com
About this study
Official title: Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)
Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.
- Conditions
- Dislocation Shoulder
- Being tested
- consultations with a psychologist, Conventional reeducation
- Keywords
- shoulder instability, kinesiophobia, Latarjet, apprehension
- Medical subject headings
- Shoulder Dislocation, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultations with a psychologistOther
Consultations with a sports psychologist to decrease kinesiophobia
Conventional reeducationOther
Conventional reeducation
| Study group | Role | What they receive |
|---|---|---|
| Convention readaptation protocol | Active comparator | Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) Receives: Other: Conventional reeducation |
| Readaptation protocol with psychologic intervention | Experimental | Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist Receives: Other: consultations with a psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability Index (WOSI)
self-evaluating shoulder instability quality of life score : 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100 mm.
Each question results in a number between 0 and 100 and the total score may be presented as a number between 0 and 2,100 points (where 0 represents no deficit and 2,100 the worst)
Measured: 6 months
Secondary outcomes (6)
Shoulder subjective value
subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
Measured: 6 months
ability to return to work
time indication
Measured: 6 months
ability to return to sport
time indication
Measured: 6 months
Patient's pain
visual analogic scale between 0 and 10
Measured: 6 months
Patient's kinesiophobia
Tampa's scale : 17 questions with scored results between 1 and 4
Measured: 6 months
S-starts test (including psychologic evaluation)
Composite score :
- Shoulder Instability-Return to Sport after Injury questionnaire (12 items each assessed on a scale from 0 to 10) quantifying the psychological readiness of athletes to return to sport following shoulder instability through evaluating emotions, confidence in performance, and perceived risk
- 4 physical performance tests
- Maximal Isometric Strength of Glenohumeral Rotator Muscles
- Y Balance Test for Upper Extremity
- Modified Closed Kinetic Chain Upper Extremity Stability Test
- Unilateral Seated Shot Put Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start29 Nov 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (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 Dislocation ShoulderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geert Alexander Buijze, MD, Principal investigator, Clinique Générale d'Annecy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154889
- Sponsor's protocol ID
- 2023-A02057-38
- Acronym
- MATASI-L
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soares MN, Shirinskiy IJ, Schachner J, Matasi Collaborator Group MCG, Macken AA, Kling A, Lafosse T, van den Bekerom MPJ, Buijze GA. Multifactorial approach training for anterior shoulder instability after a Latarjet procedure: protocol for a randomised controlled trial. BMJ Open. 2026 Jan 21;16(1):e109378. doi: 10.1136/bmjopen-2025-109378.
PubMed 41565337
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)
- ClinicalTrials.gov ID
- NCT06154889
- Acronym / sponsor ID
- MATASI-L / 2023-A02057-38
- Conditions
- Dislocation Shoulder
- Keywords
- shoulder instability, kinesiophobia, Latarjet, apprehension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Dec 2023 (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.
Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convention readaptation protocol | Active comparator | Other: Conventional reeducationPatients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) |
| Readaptation protocol with psychologic intervention | Experimental | Other: consultations with a psychologistPatient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary or recurrent traumatic anterior dislocation of the shoulder
- Indication of abutment according to Latarjet (arthroscopic or open sky)
- Age: 18-67 years
- Understanding of the French language spoken and written
- Written informed consent (in accordance with to ICH-GCP guidelines)
Key exclusion criteria (13 listed)
- Posterior or multidirectional instability of the shoulder (Beighton score >5)
- Age <18 or >67 years.
- Patients with additional rotator cuff tear.
- Patients with a history of surgery on either shoulder.
- Patients with connective tissue disorders (eg Ehler-Danlos).
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 |
|---|---|---|
| consultations with a psychologistConsultations with a sports psychologist to decrease kinesiophobia | Other | Readaptation protocol with psychologic intervention |
| Conventional reeducationConventional reeducation | Other | Convention readaptation protocol |
Primary outcome
Western Ontario Shoulder Instability Index (WOSI)
Time frame: 6 months
self-evaluating shoulder instability quality of life score : 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100 mm. Each question results in a number between 0 and 100 and the total score may be presented as a number between 0 and 2,100 points (where 0 represents no deficit and 2,100 the worst)
6 secondary outcomes
Shoulder subjective value
Time frame: 6 months
ability to return to work
Time frame: 6 months
ability to return to sport
Time frame: 6 months
Patient's pain
Time frame: 6 months
Patient's kinesiophobia
Time frame: 6 months
S-starts test (including psychologic evaluation)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 41565337Soares MN, Shirinskiy IJ, Schachner J, Matasi Collaborator Group MCG, Macken AA, Kling A, Lafosse T, van den Bekerom MPJ, Buijze GA. Multifactorial approach training for anterior shoulder instability after a Latarjet procedure: protocol for a randomised controlled trial. BMJ Open. 2026 Jan 21;16(1):e109378. doi: 10.1136/bmjopen-2025-109378.
- 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.
Geert Alexander Buijze, MD principal investigator
Clinique Générale d'Annecy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consultations with a psychologist and Conventional reeducation in people with Dislocation Shoulder, run by Clinique Générale dAnnecy 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geert Alexander Buijze, MD (+33450330950, gabuijze@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability Index (WOSI) (time frame: 6 months). 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 NCT06154889, 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 6 Apr 2026.