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Surgical Techniques for Shoulder Instability

N/A
Waitlist Available
Led By Peter Lapner, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recurrent anterior instability (dislocation or subluxation) with or without hyperlaxity, including a clinical history of traumatic anterior instability of the shoulder, with positive apprehension or relocation tests
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of enrollment up until 2-years post-operative
Awards & highlights

Study Summary

This trial is testing a new way to make decisions about shoulder surgery, to see if it leads to improved quality of life for patients.

Who is the study for?
This trial is for individuals with recurrent shoulder dislocation or instability who can consent to treatment. It's not for those with joint infections, rotator cuff injuries, previous shoulder surgeries, major illnesses limiting life expectancy, inability to understand English/French, or active worker's compensation claims.Check my eligibility
What is being tested?
The study compares two surgical methods for stabilizing the shoulder: Open Latarjet procedure and Arthroscopic Bankart repair. The decision on which surgery to use is based on a novel algorithm (ISIS Score) versus a conventional one. Success is measured by quality of life and recurrence of dislocation after one year.See study design
What are the potential side effects?
Potential side effects from these surgeries may include pain at the surgery site, infection risk, limited range of motion in the shoulder post-surgery, nerve damage around the operated area and possible need for further surgeries if stability isn't achieved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My shoulder often dislocates or feels unstable due to a previous injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of enrollment up until 2-years post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of enrollment up until 2-years post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Western Ontario Shoulder Instability Index (WOSI)
Secondary outcome measures
Adverse Events
Change in Arthritis Progression
Change in The American Shoulder and Elbow Surgeon's (ASES)

Trial Design

2Treatment groups
Active Control
Group I: Open Latarjet procedureActive Control1 Intervention
A deltopectoral approach is used. The coracoacromial ligament (CAL) is exposed and incised 1 cm from its coracoid attachment. Harvesting of a 2.5- to 3-cm coracoid graft allows use of 2 screws for fixation to the glenoid neck through a subscapularis-splitting approach. The stump of the CAL is repaired to the capsule with the arm positioned in neutral. The graft is placed in a extra-articular fashion with capsular closure to the native glenoid rim.
Group II: Arthroscopic Bankart repairActive Control1 Intervention
After the diagnostic arthroscopy is completed, any other pathology is documented. At least 3 anchors will be used for the bankart repair for repair of the labrum with an inferior to superior capsular shift. The suture anchors used will be at the discretion of the surgeon but will be of the screw-in variety. The sutures are passed through the labrum, and the labrum is tied to the glenoid rim after the bone is prepared in the standard fashion. The surgical times will be recorded on standardized forms.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,616 Total Patients Enrolled
Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital
12 Previous Clinical Trials
3,018 Total Patients Enrolled

Media Library

Arthroscopic Bankart repair Clinical Trial Eligibility Overview. Trial Name: NCT02060227 — N/A
Shoulder Dislocation Research Study Groups: Open Latarjet procedure, Arthroscopic Bankart repair
Shoulder Dislocation Clinical Trial 2023: Arthroscopic Bankart repair Highlights & Side Effects. Trial Name: NCT02060227 — N/A
Arthroscopic Bankart repair 2023 Treatment Timeline for Medical Study. Trial Name: NCT02060227 — N/A

Frequently Asked Questions

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

Is the cut-off age for this trial 70 years or younger?

"This clinical trial has a strict age range, 18-40 years old. For those under the specified age group there are 4 trials that they can participate in while patients over 65 have 6 available options."

Answered by AI

Does this research endeavor currently have vacancies for participants?

"As recorded on the clinicaltrials.gov registry, this research effort is no longer recruiting individuals to participate. The trial was first announced in March 2014 and last edited on April 19th 2022; however, there are a wealth of other studies for which patient recruitment is still active."

Answered by AI

For whom is this research endeavor open?

"This clinical trial will accept 75 participants within the age range of 18 to 40, who also exhibit joint instability."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Approach to Shoulder Instability
2014. "Approach to Shoulder Instability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02060227.
~7 spots leftby Apr 2025
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