Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

NCT ID: NCT06430567

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Patient will not use BFR

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo 10% of pressure for arterial occlusion

Patient will use BFR sub optimally as described in the literature

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:

Group 2) BFR Group with 10% AOP compression

Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15-15-15-15 at 70% 1RM

Exercise :

External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band

BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

Interventional 50% of pressure for arterial occlusion

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:

Group 1) BFR Group with 50% AOP compression

Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30-15-15-15 at 40% 1RM (repetition maximum)

Exercise :

External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band

BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

Interventions

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

Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:

Group 1) BFR Group with 50% AOP compression

Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30-15-15-15 at 40% 1RM (repetition maximum)

Exercise :

External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band

BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

Intervention Type: DEVICE

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

Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up:

Group 2) BFR Group with 10% AOP compression

Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15-15-15-15 at 70% 1RM

Exercise :

External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band

BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ensemble Hospitalier de la Côte

OTHER

Sponsor Role: lead

Responsible Party

Arnaud Meylan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bauer Stefan, MD

Role: STUDY_DIRECTOR

EHC Morges

Central Contacts

Bauer Stefan, MD

Role: CONTACT

stefan.bauer@ehc.vd.ch

0787105993 ext. +41

Arnaud Meylan, MD

Role: CONTACT

arnaud.meylan@icloud.com

0792092956 ext. +41

Other Identifiers

EHC Morges BFR

Identifier Type: -

Identifier Source: org_study_id