30 Participants Needed

Remplissage vs Latarjet Procedure for Shoulder Dislocation

Recruiting at 1 trial location
SW
Overseen ByStacey Wanlin
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Western University, Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgeries to fix shoulder dislocations in individuals with multiple dislocations and a small bone dent (Hill-Sachs defect). The treatments compared are the Bankart Repair plus Remplissage, performed with a camera and small tools, and the Latarjet procedure, which transfers a piece of bone to the shoulder. Both methods aim to improve shoulder stability. Candidates may qualify if they have experienced several shoulder dislocations and a doctor has confirmed a Hill-Sachs defect with less than 20% bone loss. As an unphased trial, this study explores innovative surgical options for enhancing shoulder stability.

Do I need to stop my current medications for the trial?

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 shows that both the Bankart Repair plus Remplissage and the Latarjet coracoid transfer are generally safe for treating shoulder instability.

For the Bankart Repair plus Remplissage, studies indicate good results with few cases of recurring dislocations. One study found that only 5.8% of shoulders experienced instability issues after this procedure. Patients often report satisfaction with pain levels, shoulder function, and range of motion post-surgery.

The Latarjet coracoid transfer is also considered safe and effective. Research shows it has a low rate of recurrent dislocations, and most patients can return to normal activities or sports. Reports indicate low infection rates and good overall outcomes.

Both treatments appear well-tolerated, with a strong safety record for individuals with shoulder instability.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for shoulder dislocation because they offer innovative surgical options that may improve outcomes for patients. The Bankart Repair plus Remplissage procedure is unique as it combines a standard arthroscopic labral repair with a technique that fills the Hill-Sachs defect, potentially reducing the risk of recurrent dislocations. On the other hand, the Latarjet Coracoid Transfer is distinctive because it involves transferring a piece of bone to the shoulder joint, which can stabilize the joint by acting as a physical block against dislocation. These approaches offer new ways to manage shoulder instability, potentially enhancing stability and reducing the chances of future dislocations compared to traditional methods.

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

This trial will compare two treatments for shoulder dislocation: Bankart Repair plus Remplissage and the Latarjet coracoid transfer. Research has shown that combining Bankart repair with remplissage effectively treats shoulder instability at the front of the shoulder. Patients experience fewer repeat dislocations and are more likely to return to sports or daily activities. This combination also helps position the upper arm bone more securely, adding stability to the joint.

Meanwhile, studies have found that the Latarjet procedure reliably treats repeated shoulder dislocations. It has a high success rate, with over 94% of patients not needing further surgery or experiencing additional dislocations. The Latarjet is a strong choice, especially if other treatments haven't worked. Both treatments are effective, but the best option depends on the patient's specific needs and the surgeon's advice.678910

Are You a Good Fit for This Trial?

This trial is for individuals over 14 years old who have had more than one shoulder dislocation and show a Hill-Sachs defect on MRI or CT scans, with less than 20% bone loss in the glenoid. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

anterior shoulder instability (>1 dislocation)
age >14 years
evidence of a Hill-Sachs defect on MRI or CT
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic Bankart repair and Remplissage or open Latarjet coracoid transfer for shoulder instability

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and post-operative outcomes using various assessments

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bankart Repair plus Remplissage
  • Latarjet coracoid transfer
Trial Overview The study compares two surgical methods for recurrent shoulder instability: arthroscopic Bankart repair plus Remplissage versus open Latarjet coracoid transfer, to see which is more effective in patients with subcritical bone loss.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Bankart Repair and RemplissageActive Control1 Intervention
Group II: Latarjet Coracoid TransferActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Panam Clinic

Collaborator

Trials
17
Recruited
1,500+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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 ...
The Pittsburgh Instability Tool Score Predicts Outcomes ...Patients who undergo ABR+R reduce PIT scores by 8 points, but scores never fall below zero. (ABR+R, arthroscopic Bankart repair plus remplissage ...
Visualizing the Effect of Arthroscopic Bankart Repair and ...Peltz et al reported that in patients with anterior shoulder instability, the humerus was significantly shifted posteriorly by 1.1 mm during the ...
Clinical outcomes and recurrence rate of 4 procedures for ...Conclusion. ASA and remplissage augmenting the Bankart repair have been demonstrated to be effective for restoring joint stability with clinical outcomes ...
Bankart Repair With or Without Concomitant Remplissage ...Purpose: To compare the results of patients who underwent Bankart repair with or without concomitant remplissage for treatment of shoulder instability.
Patient Outcomes and Fear of Returning to Sports After ...In this study, recurrence rate, pain, shoulder function, active ROM, and RTS rate were satisfactory after arthroscopic Bankart repair with remplissage.
Bankart Repair With or Without Concomitant Remplissage ...There were no significant differences in rates of redislocation (remplissage: 12.9% vs no remplissage: 9.7%), subjective instability (45.2% vs 25.8%), ...
Arthroscopic Bankart with remplissage results in lower rates of ...Pooled results, with low statistical heterogeneity, demonstrated a significantly lower rate of recurrent dislocations following Bankart repair ...
Arthroscopic Remplissage for Anterior Shoulder InstabilityOverall, 5.8% of shoulders (33 of 570) displayed recurrent instability after arthroscopic remplissage. Of the shoulders with recurrent ...
10.ijspt.scholasticahq.comijspt.scholasticahq.com/article/123481
Rehabilitation Protocol Variability Following Arthroscopic ...Augmentation of an arthroscopic Bankart repair with the remplissage (ABR) procedure has shown to confer a decrease in recurrence rates, yet, at ...
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