Shoulder Stabilization Surgery for Shoulder Dislocation

(OASIS Trial)

Recruiting at 19 trial locations

Overseen By Adam Popchak, PhD, PT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Chronic instability, Rotator cuff tears, Others

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

Compensation: Varies

Number of Visits: 6

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different shoulder surgeries for individuals with shoulder dislocations and slight bone loss. The goal is to determine which surgery enables the quickest return to regular activities, such as work or sports. Participants will undergo one of three surgeries: arthroscopic Bankart repair (a minimally invasive procedure), open Bankart, or Latarjet, each followed by rehabilitation. Suitable candidates have experienced a traumatic shoulder dislocation with 10-20% bone loss. As a Phase 2 trial, this research measures the surgeries' effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in shoulder treatment.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the arthroscopic Bankart repair reliably treats shoulder instability. Patients reported good results and excellent shoulder movement after surgery, with most studies noting a low rate of complications.

Research shows the Latarjet procedure is effective and safe, with many patients returning to their pre-surgery activity levels. This procedure stabilizes the shoulder by adding extra support, reducing the chance of dislocation.

Open Bankart surgery also yields positive results. Studies found that patients experienced better shoulder function post-surgery, with a low infection rate of around 0.33%.

Extensive research on all these procedures indicates they are generally safe and well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these surgical treatments for shoulder dislocation because they offer targeted repair techniques that could improve stability and reduce re-injury rates compared to traditional methods. The Arthroscopic Bankart repair with remplissage specifically addresses both the labral tear and the Hill-Sachs lesion, potentially enhancing shoulder stability. The Open Bankart approach provides a reliable method for direct repair of the labrum with excellent access, while the Latarjet procedure offers an innovative technique that transfers a portion of the coracoid bone to the shoulder socket, providing additional bone support. These treatments aim to improve surgical outcomes by tailoring the approach to the specific type of shoulder damage, potentially leading to more effective rehabilitation and a quicker return to full function.

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

Studies have shown that the arthroscopic Bankart repair, one of the procedures tested in this trial, effectively addresses shoulder instability. It results in fewer repeat dislocations, has low complication rates, and enables individuals to resume their activities. Another procedure in this trial, the Open Bankart surgery, also reduces shoulder instability but carries a slightly higher risk of recurrence compared to the Latarjet procedure. Research indicates that the Latarjet surgery, also tested in this trial, provides strong shoulder stability by acting like a sling to prevent dislocations. All these procedures aim to stabilize the shoulder and improve function in cases of shoulder instability. ^{2 6 7 8 9}

Who Is on the Research Team?

James J Irrgang, PhD, PT

Principal Investigator

University of Pittsburgh

Adam Popchak, PhD, PT

Principal Investigator

University of Pittsburgh

Jonathan Dickens, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for civilians and military personnel aged 17 to 50 with traumatic anterior shoulder instability and subcritical bone loss of 10-20% in the glenoid. Participants must be able to follow post-op guidelines and aim to return to their pre-injury activity levels. Those with brain injuries, vascular shoulder injuries, large humeral lesions, chronic instability, additional shoulder injuries, or prior surgeries on the affected shoulder are excluded.

Inclusion Criteria

I am between 17 and 50 years old.

Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan

I have had a shoulder dislocation due to injury.

Exclusion Criteria

You do not plan to return to the same level of work, sports, or military duty as before your injury.

My joints are unstable in many directions without any injury causing it.

I have had surgery or issues with my shoulder's rotator cuff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Rehabilitation

Participants undergo one of three surgical procedures followed by specific post-operative rehabilitation for the first 12 weeks

12 weeks

Regular visits for rehabilitation progress

Continued Rehabilitation

Rehabilitation programs are standardized and progressed based on interim testing results

12 weeks

Interim testing at 3, 4, and 6 months

Follow-up

Participants are monitored for safety, effectiveness, and outcomes such as return to duty/activity and recurrent instability

24 months

Monthly follow-ups starting at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Arthroscopic Bankart repair procedure
• Latarjet
• Open Bankart
• Post-Operative Rehabilitation

Trial Overview

The OASIS Trial compares three surgical techniques—Open Bankart repair, Arthroscopic Bankart repair procedure, Latarjet—and their subsequent rehabilitation programs. The goal is to determine which method best reduces recovery time and improves physical function after a traumatic shoulder dislocation with minor bone loss.

How Is the Trial Designed?

Group I: Open Bankart/rehabilitation Experimental Treatment 2 Interventions

Open Bankart surgery and post-operative rehabilitation.

Group II: Latarjet/rehabilitation Experimental Treatment 2 Interventions

Latarjet surgical procedure and post-operative rehabilitation.

Group III: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation Experimental Treatment 2 Interventions

Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.

Arthroscopic Bankart repair procedure is already approved in European Union, United States for the following indications:

Approved in European Union as Arthroscopic Bankart repair for:

• Shoulder instability
• Traumatic anterior shoulder dislocation
• Glenoid bone loss

Approved in United States as Arthroscopic Bankart repair for:

• Shoulder instability
• Traumatic anterior shoulder dislocation
• Glenoid bone loss

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Published Research Related to This Trial

The arthroscopic Bristow-Latarjet procedure combined with Bankart repair effectively restored shoulder stability in 98% of patients with over 20% glenoid bone loss, allowing 83% to return to sports at their preinjury level after a mean follow-up of 35 months.

The procedure maintained range of motion (ROM) with only a slight decrease in external rotation, and while 73% of coracoid grafts healed successfully, factors like short screws, smoking, and age over 35 were linked to nonunion, which could lead to persistent instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Bristow-Latarjet combined with bankart repair restores shoulder stability in patients with glenoid bone loss. Boileau, P., Thélu, CÉ., Mercier, N., et al.[2022]

Arthroscopic Bankart repair is an effective surgical option for shoulder stabilization in patients with anterior shoulder instability, particularly when there is minimal glenoid bone loss, and it has a low complication rate.

Recent studies highlight the importance of assessing glenoid bone loss before surgery, as unaddressed bone loss can lead to failure of the repair, emphasizing the need for careful patient selection to ensure successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Bankart Repair for the Management of Anterior Shoulder Instability: Indications and Outcomes. DeFroda, S., Bokshan, S., Stern, E., et al.[2023]

In a study of 41 patients over 30 years old who underwent arthroscopic Bankart repair, the long-term failure rate was found to be 37% after an average follow-up of 12 years, indicating a higher failure rate than previously reported.

Risk factors for recurrent shoulder instability included an ISIS score of 3 or higher, glenoid bone lesions, and Hill-Sachs lesions greater than 15%, suggesting that patients with these conditions may benefit from alternative stabilization techniques rather than isolated Bankart repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of arthroscopic Bankart repairs for anterior instability of the shoulder in patients aged thirty years or older. Delgrande, D., Lonjon, G., Hardy, P., et al.[2021]

In a study comparing 186 patients (93 each for Latarjet and Bankart procedures) with recurrent shoulder instability, the open Latarjet procedure resulted in significantly lower rates of recurrent instability (10% vs. 22%) over a mean follow-up of 6 years.

Patients who underwent the Latarjet procedure also reported better shoulder function, as indicated by higher Rowe scores (78 vs. 68), suggesting that this method may provide superior long-term outcomes compared to the Bankart repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The open latarjet procedure is more reliable in terms of shoulder stability than arthroscopic bankart repair. Bessière, C., Trojani, C., Carles, M., et al.[2022]

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]

In a study of 28 patients with traumatic anterior shoulder instability, arthroscopic Bankart repair successfully restored shoulder stability without any recurrence of instability in 25 patients post-surgery.

The procedure not only improved joint stability but also resulted in significantly higher scores on the MISS questionnaire, indicating better patient-reported outcomes and fewer complications compared to traditional open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthroscopic Bankart repair]. Zarzycki, W.[2014]

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]

The arthroscopic Bankart repair is the most common procedure for treating anterior shoulder instability in young athletes, but may not be sufficient for those with poor capsular tissue quality or significant bony defects.

The Latarjet procedure, which involves transferring the coracoid and its tendon, has shown reliable results for patients with chronic anterior glenoid bony defects, and the surgical technique has evolved significantly since its introduction, with over 450 procedures performed by the senior author.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical guide and tips on the all-arthroscopic Latarjet procedure. Rosso, C., Bongiorno, V., Samitier, G., et al.[2021]

The all-arthroscopic Latarjet procedure for treating anterior shoulder instability showed a low recurrence rate of only 6.1%, indicating its effectiveness in preventing chronic shoulder dislocations.

No severe neurovascular complications were reported in the study of 132 shoulders, suggesting that the procedure is safe, although some patients required re-operation due to discomfort from screw impingement or stiffness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10 Years of Arthroscopic Latarjet Procedure: Outcome and Complications. Meraner, D., Smolen, D., Sternberg, C., 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]

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