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Procedure

Surgical Treatments for Shoulder Instability

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
Recurrent anterior glenohumeral dislocation (two or more incidents)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured throughout the entire study, up to 2 years
Awards & highlights

Study Summary

This trial is testing whether arthroscopic Bankart repair or arthroscopic anatomic glenoid reconstruction is better at reducing recurrent shoulder dislocation and improving function. The feasibility objectives are to assess the ability to recruit patients and to follow patients to 24 months. Clinical objectives are to gather data on outcomes to power a future definitive trial.

Who is the study for?
This trial is for individuals with recurrent shoulder dislocations who have specific bone loss visible on imaging. It's not suitable for those with uncontrolled diabetes, pregnancy, severe illness, massive rotator cuff tears, certain levels of bone loss, posterior instability, shoulder paralysis, cancer, generalized laxity or previous surgery on the affected shoulder.Check my eligibility
What is being tested?
The study compares two surgical methods: arthroscopic Bankart repair and anatomic glenoid reconstruction to see which is better at preventing dislocations over a 24-month period. This pilot trial will test how well the study can be done across multiple sites and if patients stick to the protocol.See study design
What are the potential side effects?
Potential side effects from these surgeries may include pain at the surgery site, infection risk increase due to incisions made during surgery, limited range of motion temporarily post-surgery or complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My shoulder has dislocated at the front twice or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured throughout the entire study, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured throughout the entire study, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant Adherence
Patient Follow-up
Subject Recruitment
Secondary outcome measures
Elbow
Hand
Incidence of Recurrence
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention
The surgical technique was the lateral decubitus all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder instability as described by Wong et al. (2015). The procedure is done in a semi-lateral decubitus position that assists with optimal graft placement on the native glenoid. The investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart repair with one additional step. Prior to insertion of anchors, one additional medal portal is created for insertion of the bone graft. The distal tibia allograft is prepared; the cannulated guide is attached and advanced through the rotator interval and secured with two cannulated screws. Finally, the Bankart repair is performed above the graft. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.
Group II: Bankart RepairActive Control1 Intervention
Arthroscopic Bankart repair procedures will be performed according to each individual surgeon's usual technique. Procedures will be performed with the patient in the lateral or beach-chair position. Repairs for associated or conjoined superior labral anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's discretion. Labral detachments will be repaired with the use of suture-anchor fixation and arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion. Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,908 Total Patients Enrolled
Nova Scotia Health AuthorityLead Sponsor
255 Previous Clinical Trials
83,439 Total Patients Enrolled
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: NCT05564494 — N/A
Shoulder Instability Research Study Groups: Bankart Repair, Anatomic Glenoid Reconstruction
Shoulder Instability Clinical Trial 2023: Anatomic Glenoid Reconstruction Highlights & Side Effects. Trial Name: NCT05564494 — N/A
Anatomic Glenoid Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05564494 — N/A

Frequently Asked Questions

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

Who qualifies for enrollment in this research study?

"Applicants between the juvenescent age of 16 and a more seasoned age of 40 are eligible for this study, which is seeking to recruit around 200 participants."

Answered by AI

Is this research presently enrolling participants?

"Per the information found on clinicaltrials.gov, this particular study is not actively recruiting participants anymore; however, it was originally posted on October 12th 2022 and last updated September 30th of that same year. Fortunately, there are still 4 other medical trials currently accepting patients into their studies."

Answered by AI

Is the age threshold for this trial restricted to those aged 65 and above?

"This medical study has an age range requirement of 16 to 40, with no exceptions."

Answered by AI

What goals is this clinical trial aiming to realize?

"This trial's primary endpoint is patient follow-up over a two year period. Secondary endpoints include the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, which assigns scores from 0-100 with 100 representing worst shoulder function; strength measured using handheld dynamometers; and radiographic imaging captured through CT scans or X-Rays."

Answered by AI
~121 spots leftby Aug 2025