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Not yet recruitingNCT06430567BFRUpdated May 28, 2024

Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

An interventional study of Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability and Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability in Shoulder Dislocation, sponsored by Ensemble Hospitalier de la Côte. Not yet recruiting. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Ensemble Hospitalier de la Côte · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Dislocation

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Keywords

  • Blood flow restriction
  • Latarjet surgery
  • Rehabilitation
03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Ensemble Hospitalier de la Côte is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form for the study.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceBlood 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.

  • DeviceBlood 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.

06

What researchers measure

Primary outcomes

  1. Isokinetic strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  2. Isokinetic strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  3. Isokinetic strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  4. Isokinetic strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  5. Isokinetic strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  6. Isometric strength

    Flexion in the scapular plane (Nm)

    Time frame: Preoperative and at 14 weeks postoperative

  7. Isometric strength

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

    Time frame: Preoperative and at 14 weeks postoperative

  8. Isometric strength

    Grip test (Nm)

    Time frame: Preoperative and at 14 weeks postoperative

Secondary outcomes

  1. Shoulder mobility

    Flexion

    Time frame: Preoperative and at 14 weeks postoperative

  2. Shoulder mobility

    Abduction

    Time frame: Preoperative and at 14 weeks postoperative

  3. Shoulder mobility

    Internal rotation at 90° abduction

    Time frame: Preoperative and at 14 weeks postoperative

  4. Shoulder mobility

    External rotation at 90° abduction

    Time frame: Preoperative and at 14 weeks postoperative

  5. Shoulder mobility

    Scapular dyskinesis test (SDT)

    Time frame: Preoperative and at 14 weeks postoperative

  6. Scapular girdle stability

    Modified closed kinetic upper extremity stability test

    Time frame: Preoperative and at 14 weeks postoperative

  7. Scapular girdle stability

    Shoulder Instability Return to Sport Index (SIRSI)

    Time frame: Preoperative and at 14 weeks postoperative

  8. Scapular girdle stability

    Western Ontario Shoulder Instability Index (WOSI)

    Time frame: Preoperative and at 14 weeks postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06430567
Lead sponsor
Ensemble Hospitalier de la Côte
Responsible party
Arnaud Meylan (Doctor, Ensemble Hospitalier de la Côte) — Principal investigator
First posted
May 28, 2024
Start date
Jun 10, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
May 28, 2024

Study contacts

Bauer Stefan, MD
Contact
stefan.bauer@ehc.vd.ch
0787105993 ext. +41
Arnaud Meylan, MD
Contact
arnaud.meylan@icloud.com
0792092956 ext. +41
Bauer Stefan, MD
study director · EHC Morges

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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