Surgery vs Physical Therapy for Shoulder Dislocation

Overseen By Christian A Pearsall, BS, BA

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.

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 treatment for shoulder dislocation?

Research suggests that the Bankart repair surgery is effective for young, athletic patients with shoulder dislocations, as it helps prevent future dislocations and allows patients to return to high-demand activities without pain or instability. ^{1 2 3 4 5}

Is the Bankart repair surgery safe for treating shoulder dislocation?

The Bankart repair surgery is generally considered safe for treating shoulder dislocation, with studies showing good clinical results and high patient satisfaction. Some patients may experience a slight restriction in shoulder movement, but no major safety concerns have been reported. ^{1 6 7 8 9}

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

Arthroscopic Bankart repair is a surgical procedure specifically designed to address recurrent shoulder dislocations by repairing the damaged area of the shoulder joint, which is different from non-surgical options like physical therapy that focus on strengthening and stabilizing the shoulder without surgery. ^{4 5 10 11 12}

Research Team

David Trofa, MD

Principal Investigator

Assistant Professor of Orthopedic Surgery

Eligibility Criteria

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.

I am 12 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Does the immediate repair of Bankart lesion following first dislocation reduce the chances of recurrence after arthroscopic repair in soldiers? [2022]

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

Acute bony bankart lesion and surgical fixation. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of traumatic anterior shoulder dislocation: current status of therapy in Germany. Are there scientifically verified therapy concepts?]. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Surgical therapy of traumatic shoulder dislocation. Are there evidence-based indications for arthroscopic Bankart operation?]. [2019]

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

Anatomic Bankart repair compared with nonoperative treatment and/or arthroscopic lavage for first-time traumatic shoulder dislocation. [2022]

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

Physical Therapy Protocols for Arthroscopic Bankart Repair. [2019]

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

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

8. Poland pubmed.ncbi.nlm.nih.gov

[Results of Bankart arthroplasty procedure in the treatment of recurrent dislocation of the shoulder]. [2014]

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

Short- and long-term outcomes in Bankart repair vs. conservative treatment for first-time anterior shoulder dislocation: a systematic review and meta-analysis of randomized controlled trials. [2022]

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

Arm Abduction Provides a Better Reduction of the Bankart Lesion During Immobilization in External Rotation After an Initial Shoulder Dislocation. [2019]

11. India pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic anterior shoulder dislocation by open reduction and simultaneous Bankart lesion repair. [2021]