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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PROMIS Depression CAT at 1 year
Cat Diseases
Change in PROMIS Depression CAT at 2 weeks
+30 moreSecondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,633 Total Patients Enrolled
David Trofa, MDPrincipal InvestigatorAssistant Professor of Orthopedic Surgery
2 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My shoulder has dislocated for the first time.I cannot have general anesthesia due to health risks.My shoulder tendon detached during a scope procedure.I am 12 years old or older.I am willing and able to follow the study requirements.I have had shoulder surgery in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Operative group
- Group 2: Non-operative group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the end goals of this experiment?
"This trial's primary goal is to assess the Change in Western-Ontario Shoulder instability Index Score at 5 years. Secondary objectives include measuring Change in Constant-Murley Score, Subjective Shoulder Value Score, and Constant-Murley Score over a Baseline and 6 months time frame."
Answered by AI
Is this research still in the recruitment phase?
"Inference from clinicaltrials.gov indiciates that the recruitment of participants for this particular trial has been halted; it was initially posted on September 1st 2022 and underwent its last amendment nine days later. However, 41 other medical trials are currently enrolling patients across various sites."
Answered by AI
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