Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

NCT06430567 | Not Yet Recruiting DMC

• 1 other identifier: EHC Morges BFR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Blood flow restriction; Latarjet surgery; Rehabilitation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Shoulder mobility

  Preoperative and at 14 weeks postoperative

• Shoulder mobility

  Preoperative and at 14 weeks postoperative

• Shoulder mobility

  Preoperative and at 14 weeks postoperative

• Shoulder mobility

  Preoperative and at 14 weeks postoperative

• Shoulder mobility

  Preoperative and at 14 weeks postoperative

Study Arms (3)

Control

NO INTERVENTION

Patient will not use BFR

Placebo 10% of pressure for arterial occlusion

PLACEBO COMPARATOR

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

Interventional 50% of pressure for arterial occlusion

EXPERIMENTAL

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

Interventions

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

Interventional 50% of pressure for arterial occlusion

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

Placebo 10% of pressure for arterial occlusion

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ensemble Hospitalier de la Côte: lead

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Bauer Stefan, MD

  EHC Morges

  STUDY DIRECTOR

Central Study Contacts

Bauer Stefan, MD

CONTACT

0787105993; stefan.bauer@ehc.vd.ch

Arnaud Meylan, MD

CONTACT

0792092956; arnaud.meylan@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants between placebo and intervention group will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share