Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06430567

Blood Flow Restriction 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Isokinetic strength

    Time frame: Preoperative and at 14 weeks postoperative

    Concentric peak torque (Nm) IR-ER at 60°/sec

  2. Isokinetic strength

    Time frame: Preoperative and at 14 weeks postoperative

    Concentric peak torque (Nm) IR-ER at 240°/sec

  3. Isokinetic strength

    Time frame: Preoperative and at 14 weeks postoperative

    Eccentric peak torque (Nm) IR-ER at 60°/sec

  4. Isokinetic strength

    Time frame: Preoperative and at 14 weeks postoperative

    Concentric ratio (ER conc 60°/ IR conc 60°)

  5. Isokinetic strength

    Time frame: Preoperative and at 14 weeks postoperative

    Cocking gesture ratio (IR exc 60° /ER conc 240°)

  6. Isometric strength

    Time frame: Preoperative and at 14 weeks postoperative

    Flexion in the scapular plane (Nm)

  7. Isometric strength

    Time frame: Preoperative and at 14 weeks postoperative

    Athletic shoulder test (positions I, Y, T) (Nm)

  8. Isometric strength

    Time frame: Preoperative and at 14 weeks postoperative

    Grip test (Nm)

Secondary outcomes

  1. Shoulder mobility

    Time frame: Preoperative and at 14 weeks postoperative

    Flexion

  2. Shoulder mobility

    Time frame: Preoperative and at 14 weeks postoperative

    Abduction

  3. Shoulder mobility

    Time frame: Preoperative and at 14 weeks postoperative

    Internal rotation at 90° abduction

  4. Shoulder mobility

    Time frame: Preoperative and at 14 weeks postoperative

    External rotation at 90° abduction

  5. Shoulder mobility

    Time frame: Preoperative and at 14 weeks postoperative

    Scapular dyskinesis test (SDT)

  6. Scapular girdle stability

    Time frame: Preoperative and at 14 weeks postoperative

    Modified closed kinetic upper extremity stability test

  7. Scapular girdle stability

    Time frame: Preoperative and at 14 weeks postoperative

    Shoulder Instability Return to Sport Index (SIRSI)

  8. Scapular girdle stability

    Time frame: Preoperative and at 14 weeks postoperative

    Western Ontario Shoulder Instability Index (WOSI)

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud Meylan, MD

CONTACT

[email protected]

0792092956 ext. +41

Bauer Stefan, MD

CONTACT

[email protected]

0787105993 ext. +41

Sponsors and collaborators

Lead sponsor

Ensemble Hospitalier de la Côte

Other

Registry information

Official study title

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

Acronym: BFR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.