Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure (BFR)

Ensemble Hospitalier de la Côte

Status: Not yet enrolling

Conditions: Shoulder Dislocation

Treatments: Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability; Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability

Study type: Interventional

Funder types: Other

Identifiers

NCT06430567

EHC Morges BFR

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effects of Blood Flow Restriction (BFR) training on post-surgery rehabilitation following the Latarjet procedure in athletes aged 18-35.

The main questions it aims to answer are:

Does BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation?

Researchers will compare three groups:

BFR Group with 50% AOP [arterial occlusion pressure] compression BFR Placebo Group with 10% AOP compression Control Group

Participants will:

Perform the same four strengthening exercises twice a week Complete 16 semi-autonomous strength training sessions over 8 weeks Undergo isokinetic and isometric strength tests, shoulder mobility assessments, and complete self-assessment questionnaires.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-35 years
• Indication for shoulder stabilization surgery using the Latarjet procedure (documented anterior dislocations with proof of emergency reduction, with or without hypermobility and confirmation of traumatic capsulo-ligamentous injury by MRI).
• Regular exercise (min. 1x / week)
• Signed the informed consent form for the study.

Exclusion criteria

• Pregnant or breast-feeding women
• Active oncological disease under treatment. (Patient with stable oncological disease eligible)
• Adverse events during the 6-week post-operative period such as:-Fracture/displacement of the reconstructed bone-Luxation of the operated shoulder-Requirement for emergency hospitalization
• History of deep vein thrombosis/pulmonary embolism
• Inability to follow study procedures, due to language problems, psychological disorders, dementia.
• Need for skin grafting following shoulder stabilization surgery
• Coronary heart disease
• Unstable hypertension
• Peripheral vascular disease
• Hypercoagulable states (blood coagulation disorders)
• Left ventricular dysfunction
• Hemophilia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Control

No Intervention group

Description:

Patient will not use BFR

Placebo 10% of pressure for arterial occlusion

Placebo Comparator group

Description:

Patient will use BFR sub optimally as described in the literature

Treatment:

Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability

Interventional 50% of pressure for arterial occlusion

Experimental group

Description:

Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature

Treatment:

Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability