Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation

Overseen By Miriam Garrido Clua, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Moin Khan

Disqualifiers: Cuff tear, Epilepsy, Previous surgery, others

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

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgeries for individuals with recurrent shoulder dislocations. The first surgery, Bankart + Remplissage, involves using small instruments to tighten and repair shoulder tissues. The second, the Latarjet procedure, stabilizes the joint by moving a small piece of bone. Candidates for this trial include those who have experienced at least two shoulder dislocations due to injury and exhibit mild bone loss. The trial aims to determine which surgery more effectively prevents future dislocations and enhances shoulder function over two years. As an unphased trial, it provides an opportunity to contribute to research that could improve surgical outcomes for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that both the Bankart + Remplissage procedure and the Latarjet procedure are generally safe for treating shoulder dislocations.

Studies indicate that the Bankart + Remplissage procedure helps maintain shoulder stability, resulting in fewer post-surgery issues and excellent shoulder function. Some patients might experience slight difficulty in outward shoulder rotation, but this is usually manageable.

The Latarjet procedure is a well-known and reliable option for shoulder instability. It has been used safely and effectively for many years, with a low chance of recurrent dislocations.

In summary, both procedures are considered safe, with minor differences in outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder dislocation because they offer unique approaches to stabilizing the shoulder. The Bankart + Remplissage Procedure combines a repair of the capsulolabral complex with an additional technique to fill a defect in the shoulder bone, potentially reducing the risk of future dislocations. Meanwhile, the Latarjet Procedure involves transferring a bony structure to provide extra support to the shoulder joint, which may offer a more robust solution for preventing dislocations compared to traditional methods. These innovative techniques could provide more durable solutions for patients with recurrent shoulder dislocations, especially those who haven't found success with standard arthroscopic repairs.

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

This trial will compare the effectiveness of the Bankart + Remplissage procedure with the Latarjet procedure for treating shoulder dislocation. Studies have shown that the Bankart + Remplissage procedure often results in fewer repeat dislocations and increases the likelihood of returning to sports. This method also reduces the risk of future dislocations. The Latarjet procedure, on the other hand, is known for its long-term success in stabilizing the shoulder by moving a piece of bone within the shoulder to prevent future dislocations. Both procedures have proven effective in reducing shoulder instability, making them reliable treatment options. ^{1 3 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 adults aged 18-50 with a history of recurrent shoulder dislocation, specifically anterior dislocation confirmed by physical exam or imaging. Candidates should have mild glenoid bone loss and be able to give informed consent. It's not for those with previous shoulder surgery, epilepsy, other shoulder injuries like cuff tears, multidirectional instability, pregnancy, or certain connective tissue disorders.

Inclusion Criteria

My shoulder has dislocated at least twice due to an injury.

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

Provision of informed consent

Exclusion Criteria

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

Patients who are or at risk of being incarcerated

You are pregnant.

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

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

Regular follow-up visits as per protocol

Follow-up

Participants are monitored for recurrent dislocation rates and functional outcomes

24 months

Visits at 2 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Bankart + Remplissage Procedure
• Latarjet Procedure

Trial Overview The study compares two surgical procedures for recurrent shoulder dislocations over a period of 24 months: the Latarjet procedure (coracoid transfer) versus arthroscopic capsuloligamentous repair (Bankart + Remplissage). The goal is to see which one better prevents future dislocations and improves function.

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?

Moin Khan

Lead Sponsor

Trials

1

Recruited

90+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Campus Bio-Medico University

Collaborator

Trials

118

Recruited

58,800+

OLVG

Collaborator

Trials

25

Recruited

166,000+

Hospital Universitario La Paz

Collaborator

Trials

127

Recruited

37,900+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Queen's University

Collaborator

Hospital Universitari Vall d'Hebron Research Institute

Collaborator

Trials

253

Recruited

120,000+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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. 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.

3. 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 ...

4. 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 ...

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

The Pittsburgh Instability Tool Score Predicts Outcomes ... Results from this study suggest arthroscopic Bankart repair augmented with remplissage decreases the likelihood of recurrent instability and ...

6. 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 ...

7. 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.

8. 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 ...