Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation
(STABLE-2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McMaster University
Disqualifiers: Epilepsy, Previous shoulder surgery, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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).
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 the Latarjet procedure generally safe for shoulder dislocation treatment?
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.46789
Research Team
Moin Khan, MD
Principal Investigator
McMaster University
Eligibility Criteria
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 am between 18 and 50 years old.
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Exclusion Criteria
Cases involving litigation or workplace insurance claims (e.g. WSIB)
Patients with concomitant injuries (cuff tear)
Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score > 6
See 6 more
Trial 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 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
Treatment Details
Interventions
- Bankart + Remplissage Procedure (Procedure)
- Latarjet Procedure (Procedure)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Latarjet ProcedureExperimental Treatment1 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 ProcedureExperimental Treatment1 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 Canada for the following indications:
Approved in Canada as Bankart Procedure with Remplissage for:
- Recurrent shoulder dislocations
- Anterior shoulder instability
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Joseph's Healthcare HamiltonHamilton, Canada
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Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Trials
936
Patients Recruited
2,630,000+
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]
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]
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]
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
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]
Arthroscopic Allograft Bone Block Procedure with Remplissage for Bipolar Lesions. [2022]
The effect of open Bristow-Latarjet procedure for anterior shoulder instability: a 10-year study. [2022]
Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. [2022]
Arthroscopic Bankart Repair With Remplissage as an Alternative to Latarjet for Anterior Glenohumeral Instability With More Than 15% Glenoid Bone Loss. [2022]
Latarjet Cerclage: The All-Arthroscopic Metal-Free Fixation. [2021]
Arthroscopic Bankart-Bristow-Latarjet (2B3) Procedure: How to Do It and Tricks To Make it Easier and Safe. [2022]
Editorial Commentary: Using Bankart "Plus" Techniques to Tackle Anterior Shoulder Instability With Bone Loss: Can Newer Arthroscopic Adjuncts Provide Long-Term Stability? [2019]
Is Bristow-Latarjet operation effective for every recurrent anterior shoulder dislocation? [2019]