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RecruitingNCT06154889MATASI-LUpdated Apr 6, 2026

Rehabilitation by Multifactorial Approach After a Latarjet Procedure

An interventional study of consultations with a psychologist and Conventional reeducation in Dislocation Shoulder, sponsored by Clinique Générale dAnnecy. Recruiting at 1 site in France. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Clinique Générale dAnnecy · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dislocation Shoulder

Keywords

  • shoulder instability
  • kinesiophobia
  • Latarjet
  • apprehension
03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 52 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Clinique Générale dAnnecy is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Primary or recurrent traumatic anterior dislocation of the shoulder
  2. Indication of abutment according to Latarjet (arthroscopic or open sky)
  3. Age: 18-67 years
  4. Understanding of the French language spoken and written
  5. Written (in accordance with to ICH-GCP guidelines)

Exclusion criteria

Exclusion Criteria:

  1. Posterior or multidirectional instability of the shoulder (Beighton score >5)
  2. Age \<18 or >67 years.
  3. Patients with additional rotator cuff tear.
  4. Patients with a history of surgery on either shoulder.
  5. Patients with connective tissue disorders (eg Ehler-Danlos).
  6. Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications).
  7. Patients with neurological disorders or systemic disease.
  8. Patients with inflammatory disease, rheumatoid arthritis or active .
  9. Patients previously hospitalized for shoulder pain
  10. Patients with upper tubercle fracture
  11. Patients with motor neurological deficit
  12. Pregnant or breastfeeding patient
  13. Patient protected under protective measure
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Convention readaptation protocol

    Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)

    Other: Conventional reeducation

  • Experimental
    Readaptation protocol with psychologic intervention

    Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist

    Other: consultations with a psychologist

Interventions

  • Otherconsultations with a psychologist

    Consultations with a sports psychologist to decrease kinesiophobia

  • OtherConventional reeducation

    Conventional reeducation

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. 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%.

    Time frame: 6 months

  2. ability to return to work

    time indication

    Time frame: 6 months

  3. ability to return to sport

    time indication

    Time frame: 6 months

  4. Patient's pain

    visual analogic scale between 0 and 10

    Time frame: 6 months

  5. Patient's kinesiophobia

    Tampa's scale : 17 questions with scored results between 1 and 4

    Time frame: 6 months

  6. 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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06154889
Lead sponsor
Clinique Générale dAnnecy
Responsible party
Sponsor
First posted
Dec 4, 2023
Start date
Nov 29, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Geert Alexander Buijze, MD
Contact
gabuijze@hotmail.com
+33450330950
Geert Alexander Buijze, MD
principal investigator · Clinique Générale d'Annecy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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