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Procedure

Shoulder Surgery for Shoulder Dislocation (ATRASI Trial)

N/A
Recruiting
Led By Ivan H Wong, MD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2 or more documented incidences of anterior glenohumeral dislocation
Be younger than 65 years old
Must not have
Paralysis of the shoulder
Severe systemic illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the outcomes of two shoulder surgery options to see which is better.

Who is the study for?
This trial is for individuals who have experienced at least two documented shoulder dislocations. It's not suitable for those with multidirectional instability, pregnancy, paralysis of the shoulder, cancer, severe systemic illness, uncontrolled diabetes (Hgb A1C >7%), previous surgery on the affected shoulder or posterior instability.
What is being tested?
The study compares two arthroscopic treatments for recurrent anterior shoulder instability: anatomic glenoid reconstruction with bone graft versus Bankart repair. The effectiveness will be measured using WOSI scores and rates of re-dislocation/subluxation among other factors in a randomized controlled setting.
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection or bleeding, issues from anesthesia, pain at the surgical site, limited range of motion during recovery period and possible recurrence of dislocation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My shoulder has dislocated forward two or more times.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have paralysis in my shoulder.
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I have a serious illness affecting my whole body.
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I have had cancer in the past.
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My diabetes is not under control (Hgb A1C >7%).
Select...
I have had surgery on my shoulder before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
WOSI Score
Secondary study objectives
Recurrent Instability

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: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention
Arthroscopic distal tibia bone graft
Group II: Bankart repairActive Control1 Intervention
Arthroscopic bankart repair

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,362 Total Patients Enrolled
2 Trials studying Shoulder Dislocation
88 Patients Enrolled for Shoulder Dislocation
Ivan H Wong, MDPrincipal InvestigatorNova Scotia Health Authority
2 Previous Clinical Trials
260 Total Patients Enrolled

Media Library

Anatomic Glenoid Reconstruction (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02510625 — N/A
Shoulder Dislocation Research Study Groups: Bankart repair, Anatomic Glenoid Reconstruction
Shoulder Dislocation Clinical Trial 2023: Anatomic Glenoid Reconstruction Highlights & Side Effects. Trial Name: NCT02510625 — N/A
Anatomic Glenoid Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02510625 — N/A
~20 spots leftby Dec 2025
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