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Bankart repair for Hill-Sachs Lesion

Phase 2

Waitlist Available

Research Sponsored by Panam Clinic

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 24 months post-surgery

Awards & highlights

Study Summary

This trial compares outcomes of shoulder surgery with and without an extra procedure to help people with shoulder instability.

Who is the study for?

This trial is for individuals aged 14 or older who have a shoulder condition known as anterior instability with an associated Hill-Sachs lesion, confirmed by CT scan, MRI, or ultrasound. Participants should not have more than 15% bone loss in the glenoid area of the shoulder.Check my eligibility

What is being tested?

The study aims to compare two surgical techniques for treating shoulder instability: arthroscopic Bankart repair alone versus Bankart repair combined with infraspinatus remplissage. It's a controlled trial where patients are randomly assigned to one of these treatments.See study design

What are the potential side effects?

Potential side effects may include pain at the surgery site, limited range of motion, infection risk from surgery, and possible nerve damage. The specific risks related to remplissage procedure can also include muscle weakness or stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Western Ontario Shoulder Instability (WOSI) score

Secondary outcome measures

American Shoulder and Elbow Society assessment (ASES)

Simple Shoulder Test

Ultrasound imaging

Trial Design

2Treatment groups

Active Control

Group I: Bankart repairActive Control1 Intervention

Group II: Bankart repair and remplissageActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Panam ClinicLead Sponsor

16 Previous Clinical Trials

1,355 Total Patients Enrolled

University of OttawaOTHER

207 Previous Clinical Trials

266,991 Total Patients Enrolled

Western University, CanadaOTHER

239 Previous Clinical Trials

57,303 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA recognize Bankart repair as a viable treatment option?

"Bankart repair appears to be moderately safe based on a score of 2. This is supported by Phase 2 trial findings which provide safety data but no evidence of efficacy."

Answered by AI

Is recruitment for this experiment still ongoing?

"As evidenced on clinicaltrials.gov, this medical trial has concluded its recruitment phase. It was initially posted on March 1st 2011 and last updated on March 27th 2023. Although no longer seeking applicants, two other trials are presently looking for patients to join their research efforts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Peter MacDonald 2011. "Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01324531.