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

Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability; Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bauer Stefan, MD; Phone Number: +41 0787105993; Email: stefan.bauer@ehc.vd.ch
• Study Contact Backup: Name: Arnaud Meylan, MD; Phone Number: +41 0792092956; Email: arnaud.meylan@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patient will not use BFR
Placebo Comparator: Placebo 10% of pressure for arterial occlusion; Patient will use BFR sub optimally as described in the literature	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.
Experimental: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isokinetic strength	Concentric peak torque (Nm) IR-ER at 60°/sec	Preoperative and at 14 weeks postoperative
Isokinetic strength	Concentric peak torque (Nm) IR-ER at 240°/sec	Preoperative and at 14 weeks postoperative
Isokinetic strength	Eccentric peak torque (Nm) IR-ER at 60°/sec	Preoperative and at 14 weeks postoperative
Isokinetic strength	Concentric ratio (ER conc 60°/ IR conc 60°)	Preoperative and at 14 weeks postoperative
Isokinetic strength	Cocking gesture ratio (IR exc 60° /ER conc 240°)	Preoperative and at 14 weeks postoperative
Isometric strength	Flexion in the scapular plane (Nm)	Preoperative and at 14 weeks postoperative
Isometric strength	Athletic shoulder test (positions I, Y, T) (Nm)	Preoperative and at 14 weeks postoperative
Isometric strength	Grip test (Nm)	Preoperative and at 14 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder mobility	Flexion	Preoperative and at 14 weeks postoperative
Shoulder mobility	Abduction	Preoperative and at 14 weeks postoperative
Shoulder mobility	Internal rotation at 90° abduction	Preoperative and at 14 weeks postoperative
Shoulder mobility	External rotation at 90° abduction	Preoperative and at 14 weeks postoperative
Shoulder mobility	Scapular dyskinesis test (SDT)	Preoperative and at 14 weeks postoperative
Scapular girdle stability	Modified closed kinetic upper extremity stability test	Preoperative and at 14 weeks postoperative
Scapular girdle stability	Shoulder Instability Return to Sport Index (SIRSI)	Preoperative and at 14 weeks postoperative
Scapular girdle stability	Western Ontario Shoulder Instability Index (WOSI)	Preoperative and at 14 weeks postoperative

Collaborators and Investigators

• Sponsor: Ensemble Hospitalier de la Côte
• Investigators: Study Director: Bauer Stefan, MD, EHC Morges

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Blood flow restriction; Latarjet surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: EHC Morges BFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No