Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation

(STABLE-2 Trial)

Overseen By Moin Khan, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Epilepsy, Previous shoulder surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical treatments for recurrent shoulder dislocations. It aims to determine which procedure promotes better healing over two years. Participants will undergo either the Bankart with Remplissage procedure (also known as Arthroscopic Capsuloligamentous Repair) or the Latarjet procedure, both designed to stabilize the shoulder joint. The trial seeks individuals who have experienced at least two shoulder dislocations due to injury and have some bone loss in their shoulder joint. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance future treatment options for shoulder dislocations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Bankart + Remplissage and Latarjet procedures safely treat shoulder dislocations. Studies indicate that the Bankart + Remplissage procedure results in good shoulder function with few post-surgery issues. Patients generally recover well and experience less stiffness.

The Latarjet procedure has also proven safe and effective. Many patients return to sports with stable shoulders afterward. This procedure has a low complication rate and reliably addresses shoulder instability.

In summary, both treatments are safe and improve shoulder function in individuals with dislocations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder dislocation because they offer innovative approaches to stabilizing the shoulder joint. The Bankart + Remplissage Procedure is unique as it combines repairing the torn labrum with an additional technique to fill a defect, which might provide extra stability compared to traditional Bankart repair alone. On the other hand, the Latarjet Procedure involves transferring a bony structure to reinforce the front of the shoulder joint, potentially preventing dislocations more effectively than just repairing soft tissue. These procedures could offer improved outcomes for patients, especially those who haven't had success with existing surgical options.

What evidence suggests that this trial's treatments could be effective for shoulder dislocation?

This trial will compare the Bankart with Remplissage procedure and the Latarjet procedure for shoulder dislocation. Research has shown that the Bankart with Remplissage procedure can enhance shoulder stability. In studies, patients who underwent this procedure experienced fewer repeat dislocations and were more likely to return to sports or regular activities without issues.

For the Latarjet procedure, studies have indicated excellent long-term results for individuals with repeated shoulder dislocations. This procedure stabilizes the shoulder by moving a piece of bone to prevent future dislocations, often referred to as the "sling effect." Both procedures, tested in this trial, have strong records of improving shoulder stability and helping patients regain shoulder function. ^{3 5 6 7 8}

Who Is on the Research Team?

Moin Khan, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-50 with recurrent shoulder dislocations, specifically those who've had at least two documented episodes. They should have mild bone loss in the shoulder joint but can't be pregnant, have other shoulder injuries, a history of seizures, or any legal or insurance claims related to their injury.

Inclusion Criteria

Provision of informed consent

My shoulder has dislocated at least twice due to injury.

I have mild shoulder socket bone loss (10-20%).

Exclusion Criteria

Cases involving litigation or workplace insurance claims (e.g. WSIB)

Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score > 6

Patients with concomitant injuries (cuff tear)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Bankart + Remplissage procedure or the Latarjet procedure for shoulder stabilization

Surgery and immediate recovery

1 visit (in-person for surgery)

Post-operative Recovery

Participants recover from surgery with a sling for 4 weeks and are restricted from sports for 6 months

6 months

Follow-up visits at 2 weeks, 3 months, 6 months

Follow-up

Participants are monitored for shoulder function, stability, and complications up to 24 months post-surgery

24 months

Visits at 12 months and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bankart + Remplissage Procedure
• Latarjet Procedure

Trial Overview The STABLE trial is comparing two surgical procedures for recurrent shoulder dislocation: the arthroscopic Bankart Procedure (with or without Remplissage) versus the Latarjet procedure. The goal is to see which one gives better functional recovery after 24 months.

How Is the Trial Designed?

Group I: Latarjet Procedure Experimental Treatment 1 Intervention

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.

Group II: Bankart + Remplissage Procedure Experimental Treatment 1 Intervention

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.

Bankart + Remplissage Procedure is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bankart Procedure with Remplissage for:

• Recurrent shoulder dislocations
• Anterior shoulder instability

Approved in United States as Bankart Procedure with Remplissage for:

• Recurrent shoulder dislocations
• Anterior shoulder instability

Approved in Canada as Bankart Procedure with Remplissage for:

• Recurrent shoulder dislocations
• Anterior shoulder instability

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

The all-arthroscopic Latarjet procedure described uses a metal-free fixation method with ultra-high-strength sutures, which may reduce complications associated with metal implants in shoulder surgeries.

This technique aims to effectively treat recurrent shoulder dislocations and related injuries while maintaining the benefits of traditional Latarjet procedures, potentially offering a safer alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latarjet Cerclage: The All-Arthroscopic Metal-Free Fixation. Hachem, AI., Rondanelli S, R., Rius, X., et al.[2021]

In a study of 47 patients with more than 15% glenoid bone loss, both arthroscopic Bankart repair with remplissage (REMP) and open Latarjet procedures showed similar patient-reported outcomes and satisfaction after 2 years, indicating both are effective surgical options.

However, patients who underwent the Latarjet procedure experienced a significant improvement in external rotation compared to those who had REMP, suggesting that while both methods are effective, Latarjet may offer better functional outcomes in this specific aspect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Bankart Repair With Remplissage as an Alternative to Latarjet for Anterior Glenohumeral Instability With More Than 15% Glenoid Bone Loss. Horinek, JL., Menendez, ME., Narbona, P., et al.[2022]

The new technique of combined arthroscopic free bone grafting with remplissage for anterior shoulder instability aims to reduce complications associated with traditional Latarjet procedures, such as neurological deficits and hardware issues.

This approach may maintain effective outcomes, particularly in recurrence rates, by using remplissage to offset any potential loss of stability from the free bone graft, suggesting it could be a safer alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Allograft Bone Block Procedure with Remplissage for Bipolar Lesions. Memon, SD., Dimock, RAC., Shah, J., et al.[2022]

The Bristow-Latarjet procedure for anterior shoulder instability showed good to excellent clinical outcomes in a study of 30 patients followed for 2-8 years, with no cases of recurrent instability and no serious complications.

While there was a slight decrease in range of motion, particularly in external rotation, the procedure is a viable option for various types of shoulder instability, even in non-athletic patients, despite Bankart repair being the preferred method for isolated Bankart lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of open Bristow-Latarjet procedure for anterior shoulder instability: a 10-year study. Emami, MJ., Solooki, S., Meshksari, Z., et al.[2022]

At a 5-year follow-up, the recurrence rate of shoulder instability was significantly higher in patients who underwent arthroscopic Bankart repair (24%) compared to those who had the Latarjet procedure (12%), indicating that the Latarjet procedure may be more effective for preventing recurrence.

Younger patients (under 25), those engaging in competitive sports post-surgery, and individuals with glenoid erosion are at a higher risk for recurrence after Bankart repair, suggesting that these factors should be carefully considered when choosing surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. Bessiere, C., Trojani, C., Pélégri, C., et al.[2022]

In patients with a Hill-Sachs lesion, the Bankart repair with remplissage (BR) shows similar rates of recurrent shoulder instability compared to the Latarjet procedure, suggesting it could be a viable alternative for managing anterior shoulder instability.

While BR and Latarjet have comparable recurrence rates, the Latarjet procedure offers better external rotation range of motion post-surgery, indicating a trade-off between stability and mobility that should be considered in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bankart repair with remplissage vs. Latarjet procedure on recurrence, postoperative pain scores, external rotation, and Rowe score in patients with a Hill-Sachs lesion. A systematic review. Schrouff, CLJH., Verlaan, L.[2023]

The proposed all-arthroscopic technique combines the Bristow-Latarjet procedure with a Bankart repair, creating a '2B3 procedure' that offers three protective mechanisms for the shoulder: a labral repair for bumper effect, a coracoid bone block for bony effect, and a conjoined tendon for dynamic reinforcement.

This innovative approach allows for nearly anatomic shoulder repair and expands treatment options for patients with recurrent shoulder instability and previous failed repairs, addressing both glenoid bone loss and capsular deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Bankart-Bristow-Latarjet (2B3) Procedure: How to Do It and Tricks To Make it Easier and Safe. Boileau, P., Mercier, N., Old, J.[2022]

Arthroscopic Bankart repair combined with anatomic bone grafting (referred to as Bankart 'plus' techniques) can effectively stabilize the shoulder and reduce the risk of redislocation, especially in patients with bone loss.

These Bankart 'plus' techniques maintain a complication rate that is similar to traditional Bankart repairs, suggesting they are a safe alternative for managing anterior shoulder instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Using Bankart "Plus" Techniques to Tackle Anterior Shoulder Instability With Bone Loss: Can Newer Arthroscopic Adjuncts Provide Long-Term Stability? Gordey, EE., Wong, IH.[2019]

In a study of 35 shoulders treated with the Bristow-Latarjet procedure for recurrent anterior shoulder dislocation, 86% of patients achieved good to excellent clinical outcomes after an average follow-up of 24.6 months.

The procedure is particularly effective for patients with significant shoulder instability issues, such as large Hill-Sachs lesions or glenoid bone loss, although the Bankart operation remains preferred for cases with Bankart lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Bristow-Latarjet operation effective for every recurrent anterior shoulder dislocation? Omidi-Kashani, F., Sadri-Mahvelati, E., Mazlumi, SM., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38258962/

Arthroscopic Bankart with remplissage results in lower ... Patients undergoing arthroscopic Bankart plus remplissage for anterior shoulder instability have lower rates of recurrent instability, higher rates of return ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/03635465251340082

The Addition of Remplissage to Arthroscopic Bankart ... Overall, 43 patients (19.6%) experienced recurrent instability, with 32 (74.4%) experiencing dislocation and 11 (25.6%) experiencing subluxation ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0749806325002853

The Pittsburgh Instability Tool Score Predicts Outcomes ... The current study indicates that arthroscopic Bankart repair with remplissage augmentation can lower the rate of recurrent instability in ...

4. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-00987-4

A pilot multicenter randomized controlled trial comparing ... We will compare arthroscopic capsuloligamentous repair (Bankart repair + Remplissage) vs. coracoid transfer (Latarjet procedure) on ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/11/e089831

Multicentre randomised controlled trial comparing Bankart ... The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9756371/

Arthroscopic Bankart Repair With Remplissage as an ... REMP and Latarjet provided similar outcomes for patients with >15% GBL, although REMP patients experienced slightly decreased external rotation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05715021

RCT Evaluating First Time Shoulder Dislocation The investigators propose a multi-centre pilot RCT to compare the effect of arthroscopic surgical stabilization (Bankart procedure) and non-operative management ...

8. journals.lww.com journals.lww.com/jotr/fulltext/2022/14020/functional_outcome_of_arthroscopic_bankart_repair.6.aspx

Functional Outcome of Arthroscopic Bankart Repair With or... Arthroscopic Bankart repair for traumatic anterior shoulder instability is a good procedure with less postoperative morbidity and excellent functional outcome.