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Procedure

Surgery vs Physical Therapy for Shoulder Dislocation

N/A
Waitlist Available
Led By David Trofa, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare surgical stabilization (arthroscopic Bankart repair) to physical therapy for the treatment of primary anterior shoulder dislocations.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from arthroscopic Bankart repair include pain, infection risk at the incision site, stiffness or loss of motion. Physical therapy may cause discomfort or muscle soreness but generally has fewer risks compared to surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PROMIS Depression CAT at 1 year
Cat Diseases
Change in PROMIS Depression CAT at 2 weeks
+30 more
Secondary study objectives
Change in Constant-Murley Score at 1 year
Change in Constant-Murley Score at 10 years
Change in Constant-Murley Score at 2 weeks
+22 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Operative groupExperimental Treatment1 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 groupActive Control1 Intervention
The non-operative group will undergo physical therapy following a specific rehabilitation schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arthroscopic Bankart repair
2014
N/A
~80

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,766,925 Total Patients Enrolled
David Trofa, MDPrincipal InvestigatorAssistant Professor of Orthopedic Surgery
2 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

Arthroscopic Bankart repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05532150 — N/A
Shoulder Dislocation Research Study Groups: Operative group, Non-operative group
Shoulder Dislocation Clinical Trial 2023: Arthroscopic Bankart repair Highlights & Side Effects. Trial Name: NCT05532150 — N/A
Arthroscopic Bankart repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05532150 — N/A
~133 spots leftby Sep 2032
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