Clinical trial NCT06154889: Rehabilitation by Multifactorial Approach After a Latarjet Procedure
Official title: Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dislocation Shoulder
Keywords: shoulder instability
kinesiophobia
Latarjet
apprehension
Lead sponsor: Clinique Générale dAnnecy
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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 informed consent (in accordance with to ICH-GCP guidelines)

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 malignancy.
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

Primary outcomes:
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 6 months
Secondary outcomes:
measure: Shoulder subjective value
timeFrame: 6 months
measure: ability to return to work
timeFrame: 6 months
measure: ability to return to sport
timeFrame: 6 months
measure: Patient's pain
timeFrame: 6 months
measure: Patient's kinesiophobia
timeFrame: 6 months
measure: S-starts test (including psychologic evaluation)
timeFrame: 6 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Clinique Générale d'Annecy
Study officials:
affiliation: Clinique Générale d'Annecy
name: Geert Alexander Buijze, MD
role: PRINCIPAL_INVESTIGATOR
References: