200 Participants Needed

Surgical Treatments for Shoulder Instability

SS
MM
Overseen ByMatt Miller, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the surgical treatment for shoulder instability safe?

The surgical treatments for shoulder instability, including Arthroscopic Bankart Repair and Anatomic Glenoid Reconstruction, generally have a similar safety profile with low rates of complications like infection or nerve issues. Most patients regain normal shoulder stability, and specific techniques like using suture anchors have not shown additional complications.12345

How does the Anatomic Glenoid Reconstruction and Bankart Repair treatment differ from other treatments for shoulder instability?

The Anatomic Glenoid Reconstruction and Bankart Repair treatment is unique because it involves reattaching the labrum (a ring of cartilage) to the shoulder socket using suture anchors, which can be done arthroscopically (through small incisions) or through an open procedure. This approach helps restore shoulder stability and avoids complications associated with larger incisions, offering improved cosmetic results and outcomes similar to traditional open techniques.26789

What data supports the effectiveness of the treatment Anatomic Glenoid Reconstruction for shoulder instability?

Research shows that surgical procedures like the Bankart repair, which is part of Anatomic Glenoid Reconstruction, are effective for treating shoulder instability. Studies found that most patients regained shoulder stability and returned to their previous activity levels, with a high percentage experiencing satisfactory outcomes and no recurrent dislocations.2591011

Who Is on the Research Team?

Ivan Wong, MD | Ivan Wong, MD

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Presence of glenoid and/or humerus bone loss on imaging (X-ray, CT, or MRI)
My shoulder has dislocated at the front twice or more.

Exclusion Criteria

Multidirectional instability
I have cancer.
Posterior instability
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic Bankart repair or arthroscopic anatomic glenoid reconstruction (AAGR) for anterior shoulder instability

Surgical procedure with immediate post-operative care
1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, recurrence of dislocation, and functional outcomes

24 months
Regular follow-up visits at 6 months, 1 year, and 2 years

Long-term Follow-up

Participants continue to be monitored for long-term outcomes and recurrence rates

Additional follow-up beyond 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Anatomic Glenoid Reconstruction
  • Bankart Repair
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention
Group II: Bankart RepairActive Control1 Intervention

Anatomic Glenoid Reconstruction is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Anatomic Glenoid Reconstruction for:
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Approved in United States as Anatomic Glenoid Reconstruction for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Published Research Related to This Trial

In a study of 32 patients who underwent modified Bankart reconstruction using a suture anchor, there were no complications reported, and 93% achieved excellent or good results after an average follow-up of 42 months.
The technique allowed 26 patients to return to their pre-surgery activity levels without experiencing recurrent dislocation, highlighting its efficacy, although proper anchor placement is crucial to avoid technical failures.
Use of the suture anchor in open Bankart reconstruction. A follow-up report.Levine, WN., Richmond, JC., Donaldson, WR.[2017]
The combined arthroscopic Bankart repair and remplissage procedure (BRR) shows a low rate of recurrent dislocation at 3.4% among 220 patients followed for an average of 26 months, indicating its efficacy in managing recurrent shoulder instability.
Patients experienced no significant loss in shoulder motion after the procedure, along with favorable functional outcomes and high satisfaction rates, suggesting that BRR is a safe and effective treatment option.
Combined arthroscopic Bankart repair and remplissage for recurrent shoulder instability.Leroux, T., Bhatti, A., Khoshbin, A., et al.[2018]
In a study of 50 patients undergoing Bankart reconstruction for recurrent shoulder instability, 94% regained normal stability after 3 years, indicating high efficacy of the modified procedure using suture anchors.
The functional outcomes were satisfactory in 86% of patients, with no specific complications related to the modified technique, suggesting it is a safe and effective option for treating shoulder instability.
Repair of Bankart lesions with a suture anchor in recurrent dislocation of the shoulder.Karlsson, J., Järvholm, U., Swärd, L., et al.[2019]

Citations

Use of the suture anchor in open Bankart reconstruction. A follow-up report. [2017]
Combined arthroscopic Bankart repair and remplissage for recurrent shoulder instability. [2018]
Repair of Bankart lesions with a suture anchor in recurrent dislocation of the shoulder. [2019]
Traumatic recurrent anterior dislocation of the shoulder: two- to four-year follow-up of an anatomic open procedure. [2019]
The open-modified Bankart procedure: long-term follow-up 'a 16-26-year follow-up study'. [2021]
Arthroscopic anatomic glenoid reconstruction has a lower rate of recurrent instability compared to arthroscopic Bankart repair while otherwise maintaining a similar complication and safety profile. [2023]
Single Working Portal Technique for Knotless Arthroscopic Bankart Repair. [2020]
Risk factors for recurrence after Bankart repair a systematic review. [2022]
Arthroscopic Bankart repair: Have we finally reached a gold standard? [2022]
[Arthroscopic Bankart repair]. [2014]
Results of Open Bankart Surgery for Recurrent Anterior Shoulder Dislocation with Glenoid Bone Defect and Concomitant Hill-Sachs Lesion. [2022]
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