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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic capsuloligamentous repair (Bankart + Remplissage) vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.

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 the Latarjet procedure generally safe for shoulder dislocation treatment?

The Latarjet procedure is generally considered safe, with studies showing no screw-related or neurovascular complications, although some patients may experience mild joint wear over time. It is less invasive than some alternatives and has a low rate of recurrent instability, but there can be a slight decrease in shoulder rotation range. ^{1 2 3 4 5}

How does the Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation treatment differ from other treatments?

This treatment is unique because it combines the Bristow-Latarjet procedure with a Bankart repair, providing a triple blocking effect to stabilize the shoulder. It addresses bone loss and capsular deficiency, offering a nearly anatomic shoulder repair and extending surgical options for patients with recurrent shoulder instability. ^{4 6 7 8 9}

Research Team

Moin Khan, MD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Findings from Research

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 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 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 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]

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]

References

1. Netherlands 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. [2023]

2. Iran pubmed.ncbi.nlm.nih.gov

Arthroscopic Allograft Bone Block Procedure with Remplissage for Bipolar Lesions. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

The effect of open Bristow-Latarjet procedure for anterior shoulder instability: a 10-year study. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. [2022]

5. United States 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Latarjet Cerclage: The All-Arthroscopic Metal-Free Fixation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic Bankart-Bristow-Latarjet (2B3) Procedure: How to Do It and Tricks To Make it Easier and Safe. [2022]

8. United States 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? [2019]

9. Iran pubmed.ncbi.nlm.nih.gov

Is Bristow-Latarjet operation effective for every recurrent anterior shoulder dislocation? [2019]