Bankart + Remplissage Procedure for Shoulder Dislocation

(REDUCE Trial)

Overseen By Danielle Dagher, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Epilepsy, Pregnancy, Previous shoulder surgery, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether surgery or non-surgical options are more effective for individuals experiencing their first shoulder dislocation. The study compares a surgical method called Bankart repair (a type of shoulder surgery), with or without an additional step called Remplissage, to non-surgical treatments. It targets individuals who have dislocated their shoulder within the past three months. Participants must have experienced an anterior shoulder dislocation and confirmed it through tests or a doctor's examination. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatment options.

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.

What prior data suggests that the Bankart +/- Remplissage Procedure is safe for shoulder dislocation?

Research has shown that combining Bankart repair and Remplissage is generally well-tolerated for treating shoulder dislocations. Past studies reported a failure rate between 2% and 15%, indicating that only a small number of patients experienced issues. In another study, about 4% of patients had a positive apprehension test, indicating shoulder instability. Most patients reported excellent shoulder function after the procedure, achieving high scores on tests measuring shoulder health. Overall, the treatment appears to reduce the likelihood of the shoulder dislocating again, suggesting it is relatively safe and effective for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bankart + Remplissage procedure for shoulder dislocation because it offers a dual approach that aims to improve stability and reduce the risk of future dislocations. Unlike traditional treatments that typically focus solely on repairing the torn labrum (like the standard Bankart repair), this procedure adds the remplissage technique, which fills a bony defect in the shoulder with tissue from the surrounding area. This dual-action method not only addresses the labral tear but also tackles bone loss, which is a common issue in recurring dislocations. By doing so, it holds the promise of a more comprehensive and lasting solution for individuals with shoulder instability.

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

Research has shown that combining the Bankart procedure with remplissage for shoulder dislocation is promising. In this trial, some participants will receive the Bankart repair with remplissage, while others will receive conservative treatment. Studies indicate that the failure rate of the combined Bankart and remplissage approach ranges from 2-15%, which is quite low. Younger patients, in particular, have experienced good long-term results. This procedure significantly reduces the risk of shoulder instability during movement. Overall, evidence suggests that this treatment effectively improves shoulder stability and function. ^{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 men and women aged 14-50 who've had a first-time shoulder dislocation confirmed by X-rays or physical exam. It's not for those with previous shoulder surgery, bone defects in the glenoid, contraindications to anesthesia, pregnancy, nursing mothers, inability to have surgery, other serious injuries like full cuff tears, risk of incarceration or delayed treatment over 90 days post-dislocation.

Inclusion Criteria

I am between 14 and 40 years old.

My shoulder was dislocated for the first time in the last 3 months, confirmed by a doctor.

Provision of informed consent

Exclusion Criteria

Bony glenoid defect (bony Bankart) >10% as measured on preop imaging

I have had shoulder surgery before.

Patients that will likely have problems with maintaining follow-up or are incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either arthroscopic surgical stabilization or non-operative management for first-time shoulder dislocation

3 months

Multiple visits for surgical or physical therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 6 weeks, 6 months, 12 months, and 24 months post-treatment

Extension/Long-term follow-up

Participants may continue to be monitored for long-term outcomes and recurrence of dislocation

Additional follow-up as needed

What Are the Treatments Tested in This Trial?

Interventions

• Bankart +/- Remplissage Procedure

Trial Overview

The study compares arthroscopic soft tissue stabilization (Bankart + Remplissage Procedure) against non-surgical treatments in patients after their first shoulder dislocation. The goal is to see which method better prevents future dislocations and improves function over two years.

How Is the Trial Designed?

Group I: Bankart repair + Remplissage (randomized cohort) Experimental Treatment 1 Intervention

Arthroscopic repair of anterior capsulo-labral structures

Group II: Bankart repair + Remplissage (non-randomized cohort) Experimental Treatment 1 Intervention

Arthroscopic repair of anterior capsulo-labral structures

Group III: Conservative treatment (randomized cohort) Active Control 1 Intervention

Non surgical intervention

Group IV: Conservative treatment (non-randomized cohort) Active Control 1 Intervention

Non surgical intervention

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

Approved in European Union as Bankart Repair for:

• Anterior shoulder dislocation
• Shoulder instability

Approved in United States as Bankart Repair for:

• Anterior shoulder dislocation
• Shoulder instability

Approved in Canada as Bankart Repair for:

• Anterior shoulder dislocation
• Shoulder instability

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a study of 53 patients with recurrent anterior shoulder dislocation, adding remplissage to Bankart repair significantly reduced residual apprehension compared to Bankart repair alone, with 32% of the remplissage group experiencing apprehension versus 71.4% in the control group.

Both groups showed improvement in clinical scores post-surgery, but the remplissage group had better outcomes in ROWE scores, indicating enhanced shoulder stability without causing external rotation deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remplissage in Addition to Arthroscopic Bankart Repair for Shoulder Instability With On-Track Hill-Sachs Lesions Reduces Residual Apprehension Without External Rotation Limitation. Yu, W., Kim, H., Seo, JH., et al.[2023]

The remplissage technique, combined with Bankart lesion repair, significantly improved shoulder function in patients with recurrent anterior dislocation, as shown by a notable increase in Rowe and UCLA scores after surgery.

The procedure had a low complication rate, with only two patients experiencing recurrence of instability, and no pain reported in the infraspinatus tendon post-operation, indicating its safety and efficacy in treating glenohumeral instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RESULTS FROM FILLING "REMPLISSAGE" ARTHROSCOPIC TECHNIQUE FOR RECURRENT ANTERIOR SHOULDER DISLOCATION. Gracitelli, ME., Helito, CP., Malavolta, EA., et al.[2022]

In a study of 65 patients with recurrent anterior shoulder instability, the combination of arthroscopic remplissage and classic Bankart repair resulted in a low recurrence rate of only 5.6% for dislocations over an average follow-up of 8.1 years.

Patients reported high satisfaction with the surgical outcome, with significant improvements in shoulder function scores and no significant restrictions in shoulder range of motion, indicating that this procedure is both safe and effective for treating engaging Hill-Sachs lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of arthroscopic remplissage in addition to the classic Bankart repair for the management of recurrent anterior shoulder instability with engaging Hill-Sachs lesions. Brilakis, E., Avramidis, G., Malahias, MA., et al.[2020]

In a study of 64 elite athletes with recurrent anterior shoulder instability, the addition of the Remplissage procedure to the Bankart repair significantly improved postoperative outcomes, including higher satisfaction and lower apprehension during sports activities compared to isolated Bankart repair.

The group that underwent Bankart repair plus Remplissage had no cases of re-dislocation, while three patients in the isolated Bankart repair group experienced re-dislocation, highlighting the enhanced stability provided by the combined procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remplissage reduced sense of apprehension and increased the rate of return to sports at preinjury level of elite overhead athletes with on-track anterior shoulder instability. Kirac, M., Ergun, S., Gamli, A., et al.[2023]

In a study of 107 patients who underwent arthroscopic Bankart repair, 82 shoulders were analyzed, showing that the procedure leads to good functional outcomes with 90.2% of patients reporting good to excellent results on the Oxford Shoulder Instability Score after two years.

Despite high satisfaction rates (91.5%) and a willingness to undergo the surgery again (96.3%), 8% of patients experienced recurrence of dislocation, particularly those who played competitive sports before their injury, indicating that while the surgery is effective, some patients may still face challenges in returning to sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to sport and patient satisfaction after arthroscopic Bankart repair: a single-institution experience. Tan, YB., Puah, KL., Wah Chong, RW., et al.[2022]

In a case series of 51 patients with traumatic shoulder dislocation, arthroscopic Bankart repair showed significant improvement in shoulder function, as measured by the Rowe score, at midterm follow-up.

The procedure was found to be safe, with no major complications reported, highlighting its effectiveness as a less invasive option for managing recurrent shoulder dislocations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcome after arthroscopic management of traumatic recurrent dislocation shoulder using Bankart repair and Remplissage techniques. Sood, M., Ghai, A.[2022]

In shoulders with a 30% Hill-Sachs defect, adding the remplissage procedure to Bankart repair significantly improved joint stability and prevented dislocation, while Bankart repair alone was ineffective.

For shoulders with a 15% Hill-Sachs defect, remplissage provided minimal additional benefit and reduced certain shoulder motions, indicating that its effectiveness may depend on the size of the defect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the remplissage procedure on shoulder stability and range of motion: an in vitro biomechanical assessment. Elkinson, I., Giles, JW., Faber, KJ., et al.[2022]

The Bankart procedure is effective in improving shoulder function and reducing pain in patients with recurrent shoulder dislocation, as shown by significant improvements in various assessments like the DASH score and Rowe score after surgery.

In a study of 300 patients followed for at least one year, the surgery led to enhanced shoulder range of motion in external rotation and abduction, although some measures like forward elevation and internal rotation did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the results of Bankart repair in recurrent traumatic anterior shoulder dislocation. Mousavibaygei, SR., Moein, S., Sharifi Razavi, D., et al.[2021]

Patients who underwent arthroscopic Bankart repair with remplissage had a significantly lower recurrence rate of shoulder instability (0%) compared to those who had Bankart repair alone (22%), indicating better long-term stability after the remplissage procedure.

The remplissage group also reported higher rates of returning to sports at any level (100% vs 84.2%) and at their previous level (77.8% vs 50.0%), along with less fear of returning to sports, suggesting improved confidence and outcomes for patients after this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Outcomes and Fear of Returning to Sports After Arthroscopic Bankart Repair With Remplissage. Feng, S., Chen, M., Chen, J., et al.[2022]

Combining remplissage with an arthroscopic Bankart repair significantly reduces recurrence rates of shoulder instability and improves shoulder function compared to a Bankart repair alone, based on a systematic review of 13 studies.

However, while the remplissage procedure enhances stability, it may lead to increased stiffness and a higher loss of range of motion, indicating a trade-off between stability and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remplissage With Bankart Repair in Anterior Shoulder Instability: A Systematic Review of the Clinical and Cadaveric Literature. Alkaduhimi, H., Verweij, LPE., Willigenburg, NW., et al.[2020]

A study involving 106 patients with recurrent anterior shoulder dislocation showed that arthroscopic Bankart repair combined with Remplissage effectively improved shoulder function and stability over a follow-up period averaging 41.5 months.

While there was a slight decrease in external rotation after surgery, the procedure successfully reconstructed shoulder function and prevented further dislocations, with only one case of infection that was managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthroscopic Bankart repair combined with Reimplissage for the treatment of recurrent anterior dislocation of shoulder in adults with Hill-Sachs defect]. Xing, JS., Lu, MF., Zhao, LL., et al.[2021]

The open-modified Bankart procedure shows good long-term results for shoulder stability, with only 10% of patients experiencing redislocations after an average follow-up of 21 years.

Despite its effectiveness in reducing dislocations, the procedure does not prevent the development of osteoarthritis, as over half of the patients showed radiological signs of mild osteoarthritis in the operated shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The open-modified Bankart procedure: long-term follow-up 'a 16-26-year follow-up study'. Berendes, T., Mathijssen, N., Verburg, H., et al.[2021]

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