## Protocol Section
### Identification Module
**NCT ID:** NCT05705479

**Acronym:** STABLE-2

**Brief Title:** Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial

**Official Title:** Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation

#### Organization Study ID Info
**ID:** STABLE-2
#### Organization
**Class:** OTHER
**Full Name:** McMaster University
### Status Module
#### Completion Date
**Date:** 2027-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-17

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2023-01-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-17
**Study First Submit QC Date:** 2023-01-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** McMaster University

#### Responsible Party

**Investigator Affiliation:** McMaster University

**Investigator Full Name:** Moin Khan

**Investigator Title:** Associate Professor and Orthopaedic Surgeon

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).

**Detailed Description:** Background:

Shoulder is a highly mobile joint with the most directional range of movement compared to other joints in the body. Thus, the surrounding supporting structures of the shoulder joint compromise on the stability of the joint, in order to accomplish this wide range of motion.

Anterior dislocations, the most common type of shoulder dislocation, are often complicated by instability, and repeated dislocations. Shoulder instability results in pain and negatively impacts quality of life. Several long-term studies have demonstrated a relationship between the repeated dislocations and the risk of arthritis.

Surgical stabilization of the shoulder improves function and may reduce the risk of developing degenerative arthritis. Two procedures are commonly performed in patients with repeated dislocations: a bony transfer procedure (Latarjet) or a soft tissue procedure (Bankart + Remplissage). The Latarjet procedure involves transferring bone to the front of the shoulder. The Bankart + Remplissage procedure involves tightening the soft tissues at the front of the shoulder joint.

Although retrospective clinical studies have suggested a reduced recurrence rate with the Latarjet procedure, there is a higher reported complication rate and potential morbidity associated with the open procedure. Several case series from high-volume surgeons in Europe have suggested the Latarjet repair to be an acceptable and potentially favorable surgical approach for all cases of recurrent anterior shoulder dislocation, even in the primary setting and in the absence of significant glenoid cup bone loss. Retrospective analysis of soft tissue repair in comparison to open coracoid (Latarjet) procedure found at 10-year follow up, redislocation rates were 13% (36) of 271 shoulders with a Bankart repair and 1% (1) of the 93 shoulders with a Latarjet repair.

Need for a Pilot Study Prior to a Large Trial:

No comparative randomized control trial has been completed evaluating Bankart repair in comparison to Latarjet procedure in the setting of mild to moderate bone loss. Thus, surgeons face uncertainty regarding which procedure to perform. The Latarjet is more invasive (larger incision) and some research suggests it may be more effective at treating instability. The Bankart procedure, while minimally invasive (smaller incision), may result in higher rates of instability after surgery.

Study Aims and Objectives:

The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).

Our trial will compare arthroscopic capsuloligamentous repair vs. coracoid transfer (Latarjet procedure) on:

1. Rates of recurrent shoulder dislocations and symptoms of instability up to 24 months' post- surgery;
2. Clinical outcomes measured by American Shoulder and Elbow Society (ASES) score, Shoulder Activity Scale and EQ-5D and Patient Satisfaction Scale;
3. Physical examination: range of motion, strength, stability;
4. Return to previous level of activity;
5. Rate of shoulder-related complications and serious adverse events.

Study Design:

The investigators propose a multi-center pilot Randomized Clinical Trial of 126 patients across Canada, United States, Chile and Europe to compare the effect of capsuloligamentous repair (Bankart + Remplissage procedure) and coracoid transfer (Latarjet procedure) in patients with post-traumatic recurrent anterior dislocation. Eligible and consenting participants will be followed-up by the site for 24 months. Outcomes will be assessed at 2 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Eligible participants will be randomized to one of two treatment groups:

Arthroscopic capsuloligamentous repair (Bankart + Remplissage Procedure) Open or Arthroscopic coracoid transfer (Latarjet Procedure) Once participants have provided informed consent, baseline demographics, relevant medical history, and details regarding their diagnosis will be collected from the participant, the attending surgeon, their medical record and through physical examination. Participants will also complete The Western Ontario Shoulder Instability Index (WOSI) and he American Shoulder and Elbow Surgeons questionnaire (ASES) at the time of enrolment.

After surgery, surgical and peri-operative details will be collected from the attending surgeon and the participant's medical records. Adverse events occurring during the surgical procedure or perioperative period will also be documented.

### Conditions Module

**Conditions:**

- Shoulder Dislocation

- Sport Injuries

- Anterior Dislocation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 126

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.

**Intervention Names:**

- Procedure: Bankart + Remplissage Procedure

**Label:** Bankart + Remplissage Procedure

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.

**Intervention Names:**

- Procedure: Latarjet Procedure

**Label:** Latarjet Procedure

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bankart + Remplissage Procedure

**Description:** Participants will undergo arthroscopic stabilization.

**Name:** Bankart + Remplissage Procedure

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Latarjet Procedure

**Description:** Participants will undergo open or arthroscopic Latarjet procedure.

**Name:** Latarjet Procedure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The change from baseline to 24 months post-intervention difference in Western Ontario Shoulder Instability Index (WOSI) scores between patients with recurrent dislocations treated with Bankart Procedure + Remplissage versus Latarjet procedure.

**Measure:** Clinical Outcome - Shoulder function

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Rate of recurrent dislocation and symptomatic instability between patients randomized to (capsuloligamentous repair + remplissage) and those receiving open Latarjet procedure.

**Measure:** Rate of Recurrence

**Time Frame:** 2 years

**Description:** Measured by ASES questionnaire (American Shoulder and Elbow Surgeons)

**Measure:** Clinical Outcome

**Time Frame:** 2 years

**Description:** Measured by EQ-5D

**Measure:** Clinical Outcome - Quality of Life

**Time Frame:** 2 years

**Description:** Measured by Shoulder Activity Scale

**Measure:** Clinical Outcome - Shoulder activity

**Time Frame:** 2 years

**Description:** Measured by apprehension-relocation physical examination maneuver

**Measure:** Rate of participants with anterior shoulder instability

**Time Frame:** 2 years

**Description:** Assessed in forward flexion, abduction, external rotation and internal rotation.

**Measure:** Rate of participants with full range of motion

**Time Frame:** 2 years

**Description:** Return to previous level of activity and sport (self reported)

**Measure:** Rate of participants that return to previous level of activity

**Time Frame:** 2 years

**Description:** Adverse events

**Measure:** Rate of major and minor shoulder-related complications and serious adverse events

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Men and women ages 18-50 years;
2. Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
3. Mild glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (\>10% but \<20%);
4. Provision of informed consent.

Exclusion Criteria:

1. Patients with concomitant injuries (cuff tear);
2. Previous shoulder surgery;
3. Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
4. Epilepsy/seizure disorder;
5. Patients who are or at risk of being incarcerated;
6. Diagnosis of multidirectional instability;
7. Cases involving litigation or workplace insurance claims (e.g. WSIB);
8. Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score \> 6.
9. Pregnancy.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mgarrido@stjoes.ca

**Name:** Miriam Garrido Clua, MSc

**Phone:** khanmm2@mcmaster.ca

**Phone Ext:** 32953

**Role:** CONTACT

**Contact 2:**

**Email:** khanmm2@mcmaster.ca

**Name:** Moin Khan, MD

**Phone:** 905-522-1155

**Phone Ext:** 32953

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamilton

**Contacts:**

***Contact 1:***

- **Email:** mgarrido@stjoes.ca

- **Name:** Miriam Garrido Clua, MSc

- **Role:** CONTACT

***Contact 2:***

- **Name:** Moin Khan, MD, MSc,FRCSC

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** St. Joseph's Healthcare Hamilton

**State:** Ontario

**Status:** RECRUITING

**Zip:** L8N 4A6

#### Overall Officials

**Official 1:**

**Affiliation:** McMaster University

**Name:** Moin Khan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- 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: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M4570

- Name: Athletic Injuries

- Relevance: HIGH

- As Found: Sport Injury

- ID: M15591

- Name: Shoulder Dislocation

- Relevance: HIGH

- As Found: Shoulder Dislocation

- ID: M7385

- Name: Joint Dislocations

- Relevance: HIGH

- As Found: Dislocation

- 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: D000004204

- Term: Joint Dislocations

- ID: D000012783

- Term: Shoulder Dislocation

- ID: D000001265

- Term: Athletic Injuries

### Misc Info Module

- Version Holder: 2024-05-24
