Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability

Study Overview
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Brief Summary
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The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.

Detailed Description
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The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of AGHI up to 24-months postoperative. A secondary objective aims to address rates of return to sport (RTS) and performance in an RTS assessment in athletic patients with anterior glenohumeral instability (AGHI) who elect to undergo either surgical intervention until 24-months postoperative.

Official Title
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Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability (AGHI)

Conditions
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Anterior Shoulder Dislocation, Anterior Shoulder Instability

Intervention / Treatment
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* Procedure: Bankart Repair and Remplissage
* Procedure: Latarjet Coracoid Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 - 50 years Documented reduction of anterior shoulder dislocation Patient has suffered two or more dislocations of the study shoulder Physical examination elicits unwanted glenohumeral translation with reproduction of symptoms Glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25% Able to benefit from surgical intervention Exclusion Criteria: Glenoid defect in the affected shoulder ≥ 25% of the AP diameter of the glenoid Previous surgery on affected shoulder (ANY type of shoulder surgery) Significant shoulder comorbidities including osteoarthritis or other shoulder conditions including multi-directional instability Participant is involved in litigation or a workplace insurance claim (i.e., WCB). Confirmed connective tissue disorder (i.e., Ehlers-Danlos, Marfans) Beighton hypermobility score of >6 Active joint or systemic infection, significant muscle paralysis, rotator cuff tear arthropathy, Charcot's arthropathy, significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica) Major medical illness (life expectancy less than 1 year) or unacceptably high operative risk Epilepsy Any condition that precludes informed consent (i.e. psychiatric illness) Unable to speak or read English/French Unable or unwilling to be followed for 2 years or complete functional testing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bankart Repair and Remplissage<br>Patients will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon. | Procedure: Bankart Repair and Remplissage<br>* Arthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.<br>|
| Latarjet Coracoid Transfer<br>Patients will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws | Procedure: Latarjet Coracoid Transfer<br>* Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Shoulder Instability Index (WOSI) | Is a disease specific, quality of life patient reported outcome measures (PROMS) for patients with shoulder instability. Patients use visual analog scales (VAS) to rate physical symptoms and impacts of the condition/treatment on sports/recreation/work, lifestyle, and emotions. | 24 months | 
| Shoulder dislocation and recurrence | Dislocation requiring reduction by a physician (ED) or surgery. Dislocations will be identified in two ways: 1) if the patient seeks treatment from the surgeon, the surgeon will notify the research coordinator who will document it accordingly, or 2) at each research postoperative examination, the research staff will ask patients if they experienced a dislocation or subluxation. These will be considered alongside the definition of recurrence from Kasik et al. that also includes subluxation, or positive findings during physical examination for shoulder instability (apprehension). | 24 months | 
| Surgical complications, re-operations and revision surgeries | Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (Sokol and Wilson, 2008) (i.e., infection, dislocation, neurological injury, and fracture (including periprosthetic and acromial fracture). Revision surgery and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. Revision is defined as a change of an original component (partial or complete replacement). Re-operation is defined as any surgical procedure other than a revision. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic Internal and External Rotation | Internal and external rotation strength will be determined with an isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA). With the arm in 90 degrees shoulder abduction and elbow flexion and positioned in the scapular plane, patients will complete coupled concentric and eccentric shoulder internal and external rotation within a 90 degrees range of motion (-40 degrees internal rotation to 50 degrees external rotations). Three maximal effort (instructed to contract as hard and as fast as they can) repetitions will be completed at velocities of 60 and 180 degrees per second, with one-minute rest between testing speeds. Average peak torque of the three repetitions will be recorded for both IR and ER. | 24 months | 
| Athletic Shoulder (ASH) Test | The patient Is positioned prone with a foam block in place to support their forehand. The test is completed in three positions termed I, with the arm positioned in 180 degrees of shoulder flexion, Y, with the arm positioned in 135 degrees of shoulder abduction, and T, with the arm positioned in 90 degrees of abduction. In each position, the palm of the hand rests on a force plate (AMTI, MA, USA). The patient will complete a warm-up of two submaximal attempts in each position to 80-90% maximal effort, then three maximal effort trials for each limb in each test position (I, Y, T), with 20 seconds rest between repetitions. For each repetition, subjects will be instructed to push against the plate as hard and as fast as possible for three seconds. Peak and mean force across the three attempts and positions will be recorded. | 24 months | 
| Seated medicine ball toss | The patient will start the test in the seated position with the legs extended in front of their body, and the head, shoulders and back firmly against a wall. They will then attempt a chest pass by throwing a 10 lbs. medicine ball as far as they can. Four trials will be completed with 30 sec rest between each trial. Maximum distance will be recorded and averaged, once adjusted for arm length (distance of the ball from the wall with the arm held at 90 degrees of flexion and full elbow extension). | 24 months | 
| Posterior Shoulder Endurance Test | The patient starts positioned in prone towards one edge of a plinth, with the arm held in 90o shoulder flexion, perpendicular to the floor. Holding a weight of 2% of total body weight, the patient will attempt to raise the weight to 90 degrees of horizontal abduction, holding for one second at this position before returning to the starting position (tempo of 30 bpm). The test is terminated when the patient is fatigued as indicated by 1) the inability to hold the mid position for one second and 2) using compensatory movements of the torso, or patient request to terminate. | 24 months | 
| Plyometric Push up | Participants will start in a push up position with each hand extended in front of the shoulders and positioned on an individual force plate. When cued, the participant will lower their body to the ground by flexing at the elbow until their sternum is 3 cm from the floor. They will then forcefully extend at the elbow and propel their body into the air above the plate. During landing, the subjects will be instructed to reduce the impact as much as possible and continue for two additional repetitions. Three repetitions will be completed. Peak ground reaction forces during impact, peak rate of force development (RFD) during the concentric phase will be averaged from the three repetitions and expressed as a limb symmetry index (injured/uninjured * 100%). | 24 months | 
| Single arm seated shot put | The patient will start seated in an 18 chair without arm rests, with the legs positioned in front of their body, extended to rest straight onto an additional chair. The non-throwing arm will be placed across the chest, with a strap placed diagonally around the upper body to secure the subject to the chair. The patient will put (like shot put), and not throw (like baseball) the 6 lb. ball from shoulder height for maximal distance. Three maximal effort attempts will be recorded after a graded warm-up of four puts at 25, 50, 75 and 100% estimated effort. Thirty seconds rest will be provided between maximal attempts. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bankart repair, Remplissage, Latarjet Coracoid Transfer, Return to sport