## Protocol Section
### Identification Module
**NCT ID:** NCT06430567

**Acronym:** BFR

**Brief Title:** Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

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

#### Organization Study ID Info
**ID:** EHC Morges BFR
#### Organization
**Class:** OTHER
**Full Name:** Ensemble Hospitalier de la Côte
### Status Module
#### Completion Date
**Date:** 2027-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ensemble Hospitalier de la Côte

#### Responsible Party

**Investigator Affiliation:** Ensemble Hospitalier de la Côte

**Investigator Full Name:** Arnaud Meylan

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Shoulder Dislocation

**Keywords:**

- Blood flow restriction

- Latarjet surgery

- Rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Participants between placebo and intervention group will be blinded

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient will not use BFR

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Patient will use BFR sub optimally as described in the literature

**Intervention Names:**

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

**Label:** Placebo 10% of pressure for arterial occlusion

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

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

**Label:** Interventional 50% of pressure for arterial occlusion

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional 50% of pressure for arterial occlusion

**Description:** 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.

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

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Placebo 10% of pressure for arterial occlusion

**Description:** 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.

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

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Isokinetic strength

**Time Frame:** Preoperative and at 14 weeks postoperative

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

**Measure:** Isokinetic strength

**Time Frame:** Preoperative and at 14 weeks postoperative

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

**Measure:** Isokinetic strength

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Concentric ratio (ER conc 60°/ IR conc 60°)

**Measure:** Isokinetic strength

**Time Frame:** Preoperative and at 14 weeks postoperative

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

**Measure:** Isokinetic strength

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Flexion in the scapular plane (Nm)

**Measure:** Isometric strength

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Athletic shoulder test (positions I, Y, T) (Nm)

**Measure:** Isometric strength

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Grip test (Nm)

**Measure:** Isometric strength

**Time Frame:** Preoperative and at 14 weeks postoperative

#### Secondary Outcomes

**Description:** Flexion

**Measure:** Shoulder mobility

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Abduction

**Measure:** Shoulder mobility

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Internal rotation at 90° abduction

**Measure:** Shoulder mobility

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** External rotation at 90° abduction

**Measure:** Shoulder mobility

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Scapular dyskinesis test (SDT)

**Measure:** Shoulder mobility

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Modified closed kinetic upper extremity stability test

**Measure:** Scapular girdle stability

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Shoulder Instability Return to Sport Index (SIRSI)

**Measure:** Scapular girdle stability

**Time Frame:** Preoperative and at 14 weeks postoperative

**Description:** Western Ontario Shoulder Instability Index (WOSI)

**Measure:** Scapular girdle stability

**Time Frame:** Preoperative and at 14 weeks postoperative

### Eligibility Module

**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

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stefan.bauer@ehc.vd.ch

**Name:** Bauer Stefan, MD

**Phone:** 0787105993

**Phone Ext:** +41

**Role:** CONTACT

**Contact 2:**

**Email:** arnaud.meylan@icloud.com

**Name:** Arnaud Meylan, MD

**Phone:** 0792092956

**Phone Ext:** +41

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** EHC Morges

**Name:** Bauer Stefan, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004204

- Term: Joint Dislocations

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070599

- Term: Shoulder Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15591

- Name: Shoulder Dislocation

- Relevance: HIGH

- As Found: Shoulder Dislocation

- ID: M7385

- Name: Joint Dislocations

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012783

- Term: Shoulder Dislocation

### Misc Info Module

- Version Holder: 2024-05-31
