Surgery vs Physical Therapy for Shoulder Dislocation

Overseen By David P Trofa, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Humeral avulsion, Bony defect, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat first-time dislocated shoulders. Researchers compare two treatments: a surgical procedure called arthroscopic Bankart repair, which fixes the shoulder using tiny tools through small cuts, and a series of guided physical therapy sessions. The goal is to determine which method helps patients recover better and faster. Individuals who have recently experienced their first shoulder dislocation and are considering treatment options might be a good fit for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could shape 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.

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

A previous study found that 86% of patients who underwent arthroscopic Bankart repair regained stability and returned to sports. This suggests the surgery is generally well-tolerated, though some patients experienced repeat dislocations. Another study found a low risk of infection after this surgery compared to other surgical options.

In contrast, physical therapy for shoulder dislocation showed a very low re-dislocation rate, with only 2% of participants experiencing it again. This indicates that physical therapy is also safe and well-tolerated.

Both treatments have their advantages and are considered safe based on previous research. These findings may help prospective trial participants understand the safety of each option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for shoulder dislocation involve either surgery or physical therapy. Researchers are excited about comparing arthroscopic Bankart repair and physical therapy because each offers unique benefits. The Bankart repair is a minimally invasive surgery that directly fixes the torn labrum, potentially providing a more permanent solution to shoulder stability issues. On the other hand, physical therapy focuses on strengthening the shoulder muscles to prevent future dislocations without surgery. By evaluating these two approaches head-to-head, researchers hope to determine which is more effective for long-term recovery and stability.

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

This trial compares two treatment options for shoulder dislocation: Arthroscopic Bankart repair and physical therapy. Studies have shown mixed results regarding the effectiveness of both treatments for shoulder dislocations. Participants in the operative group will undergo Arthroscopic Bankart repair, a surgery to fix a dislocated shoulder, which has been linked to excellent long-term function but also a high risk of recurrence. Participants in the non-operative group will undergo physical therapy, which has led to significant improvements in strength and range of motion, with a low recurrence rate. Overall, surgery tends to offer better short-term and long-term outcomes for first-time dislocations, while physical therapy effectively improves shoulder stability and function. ^{2 6 7 8 9}

Who Is on the Research Team?

David P Trofa, MD

Principal Investigator

Associate Professor of Orthopaedic Surgery

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 or older who have experienced their first anterior shoulder dislocation and are seen by the Columbia University Shoulder Elbow and Sports Medicine Service. It's not suitable for those with a significant bony defect in the shoulder, previous shoulder surgery, an avulsion during arthroscopy, or if they can't follow the study protocol.

Inclusion Criteria

My shoulder has dislocated for the first time.

Patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service

I am 12 years old or older.

Exclusion Criteria

Patients lost to follow-up

I cannot have general anesthesia due to health risks.

My shoulder tendon detached during a scope procedure.

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 or physical therapy for shoulder dislocation

6 weeks

Weekly visits for therapy or post-operative check-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular follow-up visits at 3 months, 6 months, 1 year, 2 years, 5 years, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Arthroscopic Bankart repair
• Physical therapy

Trial Overview The trial compares two treatments for first-time anterior shoulder dislocations: surgical stabilization via arthroscopic Bankart repair versus non-surgical management through physical therapy. Participants will be randomly assigned to one of these approaches to determine which yields better outcomes.

How Is the Trial Designed?

Group I: Operative group Experimental Treatment 1 Intervention

The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.

Group II: Non-operative group Active Control 1 Intervention

The non-operative group will undergo physical therapy following a specific rehabilitation schedule.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39101229/

High long-term failure rates after arthroscopic Bankart ... The arthroscopic Bankart repair was associated with a high long-term recurrence rate, and its effectiveness decreased over time.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X25002892

Clinical outcomes of arthroscopic Bankart repair versus ... From five eligible cohort studies involving 3145 patients, Bankart repair was associated with elevated redislocation (RR = 3.74, CI: 1.94–7.22) and recurrence ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8449147/

Evaluating the results of Bankart repair in recurrent ... No significant changes were observed within 1 year in forward elevation (P = 0.07), internal rotation (P = 0.125) and Constant Shoulder Score (P = 0.082).

4. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(22)00341-X/fulltext

Short- and long-term outcomes in Bankart repair vs. ... This study showed that first-time anterior shoulder dislocations have better short-term and long-term outcomes when treated with Bankart repair ...

5. hannanmullettshoulderclinic.ie hannanmullettshoulderclinic.ie/wp-content/uploads/2021/03/PDF-long-term-outcomes-arthroscopic-bankart-10-years.pdf

Long-term outcomes of the arthroscopic Bankart repair ABR for anterior shoulder instability has been shown to result in excellent long-term functional outcomes despite a relatively high rate of recurrent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3543885/

Analysis of the functional results of arthroscopic Bankart repair ... At the end of our study 86% patients (43 cases) had stability compared with the normal sided shoulder and were able to return to sports, three patients involved ...

7. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00631-4/abstract

Increased Failure Rates After Arthroscopic Bankart Repair ... Average follow-up was 35.9 months. The rate of recurrent dislocation was significantly higher in the 2-dislocation group compared to single dislocations (42.8% ...

8. esmed.org esmed.org/MRA/mra/article/view/6999

Arthroscopic Bankart Repair with All Suture Anchors as ... The median Rowe score improved from 30 preoperatively to 100 at final follow-up (p<0.01), with 88.6% of patients achieving excellent outcomes.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25743570/

A Meta-Analysis of Clinical Trial Data Arthroscopic repair resulted in better recovery of range of motion, but recurrence and reoperation rates were higher than open Bankart repair.