Shoulder instability Trial comparing Arthroscopic stabilization Benefits compared with Latarjet procedure Evaluation (STABLE)

The primary outcome of the pilot study will be a composite measure of

feasibility, including:

1) Recruitment (number of patients recruited at each site during a 10-month

period),

2) Protocol adherence (number of errors in randomization); and

3) Follow-up (proportion of participants followed at two years).

We hypothesize that our feasibility outcomes will meet a priori criteria



The success of the pilot study will be based upon the following a priori

thresholds:

1) 82 patients recruited within 10 months,

2) 3 or fewer errors in randomization across the 82 enrolled patients and

treatment adherence in a minimum 66 of 82 participants (80%), and

3) 70 of 82 participants (85%) achieving complete follow-up at two years.

Secondary objectives are to evaluate:



1) Rate of recurrent dislocation and symptomatic instability between patients

randomized to (capsuloligamentous repair +/- remplissage) and those receiving

open Latarjet procedure. This outcome is critically patient important and is

objectively documented in the case of shoulder dislocation or in the case of

recurrent symptomatic instability will be patient reported at follow up.



2) Clinical outcomes measured by Western Ontario Shoulder Instability (WOSI)

Index, American Shoulder and Elbow Society (ASES) score, Patient Satisfaction

Scale, Shoulder Activity Scale and EQ-5D;,

The WOSI is a self-administered quality of life outcome measure designed for

clinical trials evaluating treatments for patients with shoulder instability.

It has been shown to have high reliability, validity and responsiveness31. The

WOSI score is commonly utilized and has been shown to provide excellent ability

to detect variability in severity of post-operative instability symptoms

including following shoulder stabilization procedures30.

The ASES score is designed to assess shoulder function including instability29.

It allows for patient self-evaluation through 11 items that can be used to

generate a score, divided into 2 areas: pain (1 item) and function (10 items).



Functional outcome assessment will be patient reported on paper through

post-operative follow up forms administered by the study coordinator or

designate at each site.

3) Physical examination: range of motion, strength, stability;

Physical examination following surgery will be performed by the operating

surgeon and will consist of functional assessment important to patients. Range

of motion and strength as well as assessment of shoulder stability are commonly

reported outcome measures in the literature when assessing success following

shoulder instability surgery1,38. Range of motion will be assessed in forward

flexion, abduction, external rotation and internal rotation.

Strength will be assessed on a five-point scale 0/5: no contraction, 1/5:

muscle flicker, but no movement, 2/5: movement possible, but not against

gravity (test the joint in its horizontal plane), 3/5: movement possible

against gravity, but not against resistance by the examiner, 4/5: movement

possible against some resistance by the examiner and 5/5: normal strength.

Stability will be assessed primarily via the apprehension- relocation physical

examination maneuver which has demonstrated the highest sensitivity in the

literature for the diagnosis of anterior instability.



4) Return to previous level of activity and sport

The majority of shoulder instability affects young individuals involved in

athletic activities and sport. An important aspect in the success of surgical

intervention is to return patients back to previous and desired level of

activity6. This outcome will be patient reported at follow up.



5) Rate of major and minor shoulder-related complications and serious adverse

events

Major complications will include, symptomatic non-union of transferred bone

block, hardware penetration into the joint, neurological or vascular injury or

deep vein thrombosis.