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Shoulder InstabilityNCT05564494

Surgical Treatment of Recurrent Shoulder Dislocations

A study testing Bankart Repair and Anatomic Glenoid Reconstruction in people with Shoulder Instability, run by Nova Scotia Health Authority at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 16 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Shoulder Instability
What is being tested?
Bankart Repair and Anatomic Glenoid Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesin 2 countries
Study dates
25 Apr 2023to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Recurrent anterior glenohumeral dislocation (two or more incidents)
  • Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)

Who cannot join

  • Uncontrolled diabetes (Hgb A1C >7%)
  • Prior surgery of affected shoulder
  • Pregnancy
  • Multidirectional instability
  • Posterior instability
  • Paralysis of the shoulder
Show all 11Show fewer
  • Cancer
  • Severe systemic illness
  • Presence of massive rotator cuff tear
  • Patients that present with < 10% or > 25% bone loss under preoperative imaging.
  • Generalized laxity (>5/9 Beighton Score)

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Matt Miller, PhD contact

9024737626

research@drivanwong.com

2 sites in 2 countries

United States1 site, 1 recruiting
  • NYU Langone Health

    New York, New York, 10016

    Jade Refuerzo, 646-929-7800, Jade.Refuerzo@nyulangone.org

    Daniel Kaplan, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting
  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2E1

    Sara Sparavalo, MASc, 9024737626, research@drivanwong.com

    Ivan H Wong, MD

    Recruiting

Other trials in Canada

About this study

Official title: The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled 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.

Read the detailed description

The glenohumeral joint has the greatest range of motion of any major articulation in the human body. This increased mobility leaves the joint vulnerable to dislocation and the development of instability and osteoarthritis, both of which can have drastic effects on work productivity and quality of life. Symptomatic instability following anterior glenohumeral dislocation is especially common among young people. In patients under 20 years of age, recurrent dislocation rates may be as high as 90%. The high incidence of recurrent dislocation negatively affects the individual and society in general. It may limit range of movement and can require multiple hospital visits for treatment and surgical procedures to prevent further dislocations. Chronic instability of the joint may prevent the individual from participating in sports and physical activity, and from returning to work, and leads to osteoarthritis. The development of osteoarthritis in young patients is devastating and leads to changes within the shoulder that are not easily repairable and results in the need for early shoulder replacements which are costly for both the healthcare system and for the patient themselves. It has been well-established in the literature that surgical management of anterior shoulder instability provides a lower recurrence rate and better rates of return to sport than non-operative treatment. Non-operative treatment of primary anterior shoulder instability has been found to have a high rate of progression to arthritis at a long term follow-up, due to recurrence.

Recurrence rates are influenced by multiple factors including age and gender of the patient, contact sport participation, ligamentous laxity, and the bone loss both on the glenoid and humerus. Of these factors, bone loss is the only modifiable factor. Glenoid defects, present in 22% of patients with acute dislocations, are found in 73% of recurrent dislocations. The management of glenoid bone deficiency in shoulder instability has been a challenge to surgeons for many years. Anteroinferior glenoid bone loss is a significant contributor to recurrent instability through alteration of both the glenohumeral joint contact area and congruency of the articular surfaces. Previous researchers outlined the additive effect of humeral and glenoid bone loss in contributing to shoulder instability and stressed the importance of bony procedures in creating a stable shoulder, particularly for the young active patient. For patients with large anterior glenoid defects (>25%) or other risk factors for recurrence, bone grafting procedures, including autogenous coracoid transfer to the anterior glenoid (i.e. Latarjet procedure) as well as iliac crest autograft and tibial allografts (i.e. arthroscopic anatomic glenoid reconstruction (AAGR)) have been described. These procedures have all been shown to be equally effective and reliable techniques for treating shoulder instability.

The most common pathology in recurrent shoulder instability is anteroinferior capsulolabral avulsion. In 1938, Bankart described the detachment of the anterior inferior labrum from the glenoid rim as a cause of anterior instability and presented his case report of 27 patients treated surgically. In recent years, technical advancements in arthroscopic shoulder surgery have radically altered the treatment of anterior shoulder instability. Arthroscopic techniques have been developed in an attempt to reduce common challenges of open repair including wide dissection, loss of external rotation and post-operative pain. Arthroscopic labral repair, now considered routine and reliable, is the treatment of choice for many cases of recurrent anterior shoulder instability in North America.

Although the results of arthroscopic anterior labral repair using current techniques have been shown to parallel results of open anterior stabilizations in most patients, it is recognized that arthroscopic labral repair is less effective in patients with risk factors for failure such as young age, hyperlaxity, competitive contact sport participation, and in particular glenoid or humeral bone loss. A recently published long-term study on patient outcomes following isolated arthroscopic Bankart repair found a high rate of recurrence and development of arthritis at a 9-12- year follow-up. The authors state that an isolated Bankart repair does not solve the issue of glenoid bone loss.

While bony procedures have traditionally been reserved for cases with bone loss of the glenoid or humerus (so-called Hill-Sachs lesions), there are some regions in which surgeons prefer this type of procedure regardless of the degree of bone loss. This is in part due to recent findings revealing that bone loss may be underestimated by current methods of preoperative measurement. Currently, there are three common methods used to assess bone loss. Preoperative CT and MRI are employed to quantify bone defects, and arthroscopic evaluation may also be used.

There is much controversy over the most accurate method of quantifying bone loss. CT evaluation of glenoid bone loss pre-operatively has been shown to underestimate bone loss.. The absence of a validated non-invasive pre-operative imaging modality has led many surgeons to utilize bony procedures more aggressively, despite limited findings of bone loss on pre-operative imaging. One survey revealed that, irrespective of the types of patients and lesions, 72% of French shoulder surgeons prefer bone block procedures for treating traumatic recurrent anterior shoulder instability. This is in stark contrast to the findings of a large international survey, in which 90% of shoulder surgeons in other countries preferred arthroscopic Bankart repair. Rates of recurrence after these two techniques vary widely in the literature, ranging from 0% to 30% for arthroscopic Bankart repair, with a mean of 9%, and from 2% to 14% for the open Latarjet bone block procedure, with a mean of 7%.

In recent years, trends toward minimally invasive shoulder surgery along with improvements in technology and technique have led surgeons to expand the application of arthroscopic treatment. Techniques have been developed to treat severe instability with or without associated bone loss using arthroscopic bone allograft and autograft augmentation. These approaches seek to provide a nearly anatomic reconstruction of the glenohumeral joint by treating the soft tissue and the bony lesions. Advantages of an arthroscopic approach include smaller incisions, less disruption of the subscapularis, and the ability to evaluate the joint for other intra-articular lesions. The view afforded by the camera may allow for more accurate placement of the graft in the joint.

Rates of instability recurrence after Bankart and bone block procedures vary widely in the literature, ranging from 0% to 30% for arthroscopic Bankart repair and from 2% to 14% for the bone block procedures . A recent systematic review cites the recurrence rates for these two procedures to be 19.5% and 8.7%, respectively. Patients with recurrent dislocations and 25% bone loss make up the majority of instability patients, as opposed to first-time dislocators and patients with >25% bone loss. There is no consensus on the best treatment type for patients with recurrent anterior shoulder instability with subcritical (<25%) bone loss. However, most of the evidence to support bone grafting over soft tissue repair in this patient population has been retrospective, and there has been no randomized controlled trial comparing Bankart with a bone block technique, data regarding newer arthroscopic bony glenoid augmentation is even more limited.

While a multi-site, double-blinded-randomized controlled trial would provide the best evidence for the preferred technique, the feasibility of such a project is unknown. The investigators therefore propose a pilot multi-site, double-blinded randomized controlled trial to compare the outcomes of arthroscopic Bankart repair with those of arthroscopic Bankart repair plus bony glenoid augmentation (i.e. AAGR). The goal of this pilot is to assess the feasibility of recruiting patients across multiple sites while adhering to study protocols before conducting a definitive RCT which requires more resources (financial and otherwise). Additionally, most of the data on the AAGR technique is from a single surgeon and the investigators need to ensure that the results and outcomes are generalizable across multiple surgeons and multiple sites.

Being tested
Bankart Repair, Anatomic Glenoid Reconstruction
Keywords
Arthroscopy, Shoulder Instability, Multiple Dislocations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bankart RepairProcedure or surgery

    Also called Arthroscopic bankart repair

    Patients Randomized to Bankart Repair Group

  • Anatomic Glenoid ReconstructionProcedure or surgery

    Also called Arthroscopic distal tibia bone graft

    Patients Randomized to Anatomic Glenoid Reconstruction Group

Study groups in NCT05564494
Study groupRoleWhat they receive
Bankart RepairActive comparatorArthroscopic 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.
Receives: Procedure: Bankart Repair
Anatomic Glenoid ReconstructionExperimentalThe 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.
Receives: Procedure: Anatomic Glenoid Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject Recruitment

    Recruitment of 100 participants

    Measured: Measured throughout the entire study, up to 2 years

  2. Participant Adherence

    Protocol adherence

    Measured: Measured throughout the entire study, up to 2 years

  3. Patient Follow-up

    Proportion of Patients Followed at 24 months

    Measured: Measured throughout the entire study, up to 2 years

Secondary outcomes (9)
  1. The Western Ontario Shoulder Instability Index (WOSI)

    This questionnaire is used to measure shoulder related quality of life in the participants. The range of possible scores is 0-100, with 0 representing no deficits and 100 representing the worst deficits.

    Measured: Measured at 6 month, 1 year, and 2 year time points

  2. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form

    This questionnaire is used to evaluate shoulder function, the possible range of scores is 0-100, with 0 representing the best score and 100 representing the worst score.

    Measured: Measured at 6 month, 1 year, and 2 year time points

  3. Disabilities of the Arm, Shoulder, and Hand (DASH)

    This is a questionnaire used to measure the physical function of the participants, scores range from 0-100 with 0 being the best score and 100 being the worst score possible.

    Measured: Measured at 6 month, 1 year, and 2 year time points

  4. MARX Physical Activity Questionnaire

    This questionnaire is used to assess the physical activity status of the participants, the possible scores range from 0-16 with 16 being the best possible score.

    Measured: Measured at 6 month, 1 year, and 2 year time points

  5. Quality of Life Assessment (EQ-5D-5L)

    This questionnaire is used to assess the quality of life of the participants, possible scores range from 0-25 with 0 being the best possible score and 25 being the worst score.

    Measured: Measured at 6 month, 1 year, and 2 year time points

  6. Strength

    Measurement of shoulder strength using a handheld dynamometer

    Measured: Measured at 6 month, 1 year, and 2 year time points

  7. Incidence of Recurrence

    How often a subsequent shoulder dislocation occurs, measured with patient report data

    Measured: Measured at 6 month, 1 year, and 2 year time points

  8. Range of Motion

    Measurement of shoulder range of motion, measured with handheld goniometer

    Measured: Measured at 6 month, 1 year, and 2 year time points

  9. Radiographic Imaging

    Measured by observing CT scans and X-Rays

    Measured: Measured with at least one CT and one x-ray at any time point prior to surgery and once post surgery up to a year after the surgery. The post surgical time frames for this imaging may differ depending on booking, availability, and wait times

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start25 Apr 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a pilot multi-center, double-blinded, RCT of a minimum of 100 patients, performed in five cities at seven sites (Calgary (2 sites), Winnipeg (2 sites), Montreal, Halifax, and Ottawa).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564494
Sponsor's protocol ID
50028
Status last verified
Apr 2026
First submitted
15 Sep 2022
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bankart Repair and Anatomic Glenoid Reconstruction in people with Shoulder Instability, run by Nova Scotia Health Authority at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matt Miller, PhD (9024737626, research@drivanwong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Recruitment (time frame: Measured throughout the entire study, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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