Bankart + Remplissage Procedure for Shoulder Dislocation

(REDUCE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Moin Khan, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Disqualifiers: Epilepsy, Pregnancy, Previous shoulder surgery, others

No Placebo Group

Approved in 4 Jurisdictions

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 soft tissue stabilization vs. non-operative management on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FTD) over a 24-month period.

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 data supports the effectiveness of the Bankart + Remplissage treatment for shoulder dislocation?

Research shows that adding the remplissage procedure to the Bankart repair can reduce feelings of instability in the shoulder without limiting movement, and patients generally report satisfaction with their ability to return to sports after these procedures. ^{1 2 3 4 5}

Is the Bankart + Remplissage procedure safe for treating shoulder dislocation?

The Bankart and Remplissage procedures are generally considered safe for treating shoulder dislocation, with studies showing they help reduce fear of re-injury and improve return to sports without causing significant movement limitations. ^{1 6 7 8 9}

How does the Bankart + Remplissage treatment differ from other treatments for shoulder dislocation?

The Bankart + Remplissage treatment is unique because it combines two surgical techniques to address shoulder dislocation, particularly when there is a Hill-Sachs defect (a bone injury on the head of the upper arm bone). The Bankart repair stabilizes the shoulder joint, while the Remplissage technique fills the defect to prevent further dislocations, offering a comprehensive approach to shoulder stability. ^{1 5 10 11 12}

Research Team

Moin Khan, MD

Principal Investigator

McMaster University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Bankart +/- Remplissage Procedure (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.

Participant Groups

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 Canada for the following indications:

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+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Return to sport and patient satisfaction after arthroscopic Bankart repair: a single-institution experience. [2022]

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

Remplissage With Bankart Repair in Anterior Shoulder Instability: A Systematic Review of the Clinical and Cadaveric Literature. [2020]

4. Germany 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. [2020]

5. India pubmed.ncbi.nlm.nih.gov

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

6. Germany 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. [2023]

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

Patient Outcomes and Fear of Returning to Sports After Arthroscopic Bankart Repair With Remplissage. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

RESULTS FROM FILLING "REMPLISSAGE" ARTHROSCOPIC TECHNIQUE FOR RECURRENT ANTERIOR SHOULDER DISLOCATION. [2022]

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

Evaluating the results of Bankart repair in recurrent traumatic anterior shoulder dislocation. [2021]

10. China 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]. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

The open-modified Bankart procedure: long-term follow-up 'a 16-26-year follow-up study'. [2021]

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

The effect of the remplissage procedure on shoulder stability and range of motion: an in vitro biomechanical assessment. [2022]