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Recruiting NCT06154889

Rehabilitation by Multifactorial Approach After a Latarjet Procedure

No phase Interventional Dislocation Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: consultations with a psychologist, Conventional reeducation.
Who it may be relevant to
Registry conditions: Dislocation Shoulder. Basic parameters: 18 years — 67 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)

Overview

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.

Interventions

  • Other consultations with a psychologist
    Consultations with a sports psychologist to decrease kinesiophobia
  • Other Conventional reeducation
    Conventional reeducation

Primary outcome measures

  • Western Ontario Shoulder Instability Index (WOSI) [Time frame: 6 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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).
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Clinique Générale d'Annecy — Annecy

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. PMID 41565337

Identifiers

NCT: NCT06154889 · 2023-A02057-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗