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SNCTP000003719

Mobilisation post-opératoire après stabilisation glénohumérale antérieure selon Latarjet: écharpe versus rien. Une étude prospective randomisée.

Data source: BASEC (Imported from 24.05.2020)
Changed: 07.04.2020
Disease category: Muskel-Skelett-Erkrankungen (nicht Krebs)

Brief description of trial (Source of data: BASEC)

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after Latarjet procedure for treatment of anterior shoulder instability. Ultimately, the goal would be to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to activities of daily living, work and sport.

Health conditions investigated (Source of data: BASEC)

Instabilité d'épaule

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

This prospective case-control clinical study is randomized 1:1 between sling-wearing group and no-sling group. This superiority trial that includes 68 patients that have benefited from Latarjet procedure for treatment of anterior shoulder instability. The control group will wear a sling during the first 3 post-operative weeks. Interventional group will not wear any brace. Both groups will move passively during the first 3 weeks. Clinical follow-up will be performed by investigators. Clinical follow-up will last 12 months17,24. This period is thought to be sufficient to identify differences between both groups as they are expected to appear early in the follow-up25. Furthermore reported graft union rate at six months is >90%, and hardware related complications known to be detected early17,26.

Criteria for participation in trial (Source of data: BASEC)

Between February 2020 and December 2021, all patients over 18 years old who have an anterior shoulder instability with one of the following criteria: an anterior glenoid bone defect > 20%, contact athlete or patients with failed Bankart repair—either open or arthroscopic will be considered eligible11,27.

Exclusion criteria (Source of data: BASEC)

We exclude patients with a subscapularis tear, other trauma of the involved upper extremity (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation), pre-operative stiffness, pre-operative sign of dislocation on standard X-ray, CT, CT arthrogram, MRI or MRA, contra-indication to CT (i.e pregnancy), and an inability to follow properly post-surgery recommendations11

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Genf

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Lädermann
+41787921975
alexandre.laedermann@gmail.com

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-02469