Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

Study Overview
=================
Brief Summary
-----------------
Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function. Hypothesis: Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.

Conditions
-----------------
Recurrent Shoulder Dislocations

Intervention / Treatment
-----------------
* Procedure: Arthroscopic Bankart repair
* Procedure: ABR+ARIC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16-40 years old Anterior Shoulder instability Hyperlaxity (general and shoulder laxity) Exclusion Criteria: Previous humerus/glenoid fracture large bony Bankart Previous shoulder operation Adhesive capsulitis-Habitual dislocations

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic Bankart repair<br> | Procedure: Arthroscopic Bankart repair<br>* Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.<br>|
| Active Comparator: ABR+ARIC<br> | Procedure: ABR+ARIC<br>* Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Through additional anterior superior portal a suture is passed inferior and adjacent to the SSP and through the superior portion of the Sub Scapularis tendon while the arm in 30 degree of external rotation. Tightening the suture on top of the capsule underneath the deltoid. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent shoulder dislocation or instability symptoms |  | Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative range of motion (ROM) |  | Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up. | 
| Activity level |  | Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up. | 
| Need for recurrent surgery |  | Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up. | 
| Pain |  | Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ABD, ABDuction, ABR, Arthroscopic Bankart Repair, ACJ, AcromioClavicular Joint, AD, Anterior Drawer, ARIC, Arthroscopic Rotator Interval Closure, BL, Bankart Lesion, CHL, CoracoHumeral Ligament, ER, External Rotation, FF, Forward Flexion, GHJ, GlenoHumeral Joint, HSL, HillSacs Lesion, IR, Internal Rotation, ISP, InfraSPinatus, PD, Posterior Drawer, RI, Rotator Interval, ROM, Range Of Motion, SGHL, Superior GlenoHumeral Ligament, SSC, SubSCapularis, SSP, SupraSPinatus