Randomized trial Evaluating first time shoulder Dislocation: sUrgery vs Conservative carE (REDUCE)

The shoulder is the most commonly dislocated joint in the body with a global
incidence that ranges from 15 to 25 per 100 000 people. The estimated annual
societal cost in North America due to first-time shoulder dislocations exceeds
$1.2 billion CAD.
Anterior dislocations, the most common type of shoulder dislocation, are often
complicated by subsequent instability and recurrent dislocation, with reported
rates as high as 47%. Shoulder instability commonly results in pain and
negatively impacts quality of life.
Current standard of care suggests surgical stabilization of the shoulder after
two or more dislocations, but the evidence is far from conclusive.
Observational studies suggest that early surgical stabilization has strong
biological rationale in limited risks of recurrent dislocation, improving
quality of life, and potentially decreasing the future risk of shoulder
arthritis. Also, some economic health studies suggests that surgery is less
costly and more effective, even after recurrent dislocations.

The primary objective of the pilot study is to assess the feasibility of a
definitive trial to determine the effect of arthroscopic soft tissue
stabilization vs. non-surgical treatment on rates of recurrent anterior
dislocation and functional outcomes in patients presenting with a first-time
dislocation (FTD) over a 24-month period.

We propose a multi-centre pilot RCT of 50 participants across Canada, the
United States, South America, and Europe to compare the effect of arthroscopic
soft tissue stabilization (Bankart procedure) and non-operative treatment
(physical therapy) in patients with a post-traumatic anterior FTD. Eligible and
consenting participants will be followed-up by the site for 24 months. Outcomes
will be assessed at 6 weeks, 6 months, 12 months, and 24 months post-treatment.

Participants will undergo arthroscopic soft tissue stabilization (Bankart
procedure) or non-surgical treatment as described below.

Arthroscopic Stabilization (Intervention)
Patients randomized to surgical intervention will be required to undergo
surgery within 3 months of enrollment. Advanced imaging will be obtained prior
to surgery, including MRI, MR arthrogram or preoperative CT scan for assessment
of pathology. For arthroscopic Bankart repair, the participant will be placed
in the lateral decubitus or beach chair position. Standard diagnostic
arthroscopy will be performed. The capsulolabral complex will be freed from the
anterior aspect of the scapular neck. The anterior aspect of the scapular neck
will be decorticated using a motorized burr. A capsuloligamentous repair will
be performed with the capsule shifted from inferior to superior and repaired on
the glenoid face. The number of anchors used for the repair will be left to the
discretion of the surgeon (a minimum of 3 anchors recommended). Remplissage
procedure will be performed at the discretion of the operating surgeon.
All participants will follow a standardized rehabilitation protocol following
surgical intervention: Phase I: Immediate postop phase (0-6 weeks) in sling,
Passive range of movement, Phase II: Active motion phase (5-8 weeks after
surgery), Phase III: Strengthening phase (8-12 weeks after surgery), Phase IV:
Advanced strengthening phase (12 weeks and beyond).

Non-surgical treatment (Control Group)
Type of sling and immobilization will be left to the discretion of the
operating surgeon. Patients randomized to non-surgical treatment will begin
early physical therapy (PT) immediately as per protocol (2 weeks after initial
immobilization). All participants will follow a standardized 3 phase
rehabilitation protocol following 2 weeks of immobilization.

Following the initial urgent management and relocation of a dislocated
shoulder, the prevention of recurrent instability is the critical management
consideration for health care providers and surgeons. Two initial management
options exist in patients with a FTD: non-operative care or surgical
stabilization.
Recent research and available evidence over the past 10 years have called into
question the role of a delayed approach to managing FTDs for a number of
reasons. Surgical management has been suggested as a more reliable option to
prevent further dislocations and improve patient outcomes when compared with
non-operative management. Arthroscopic soft tissue repair (Bankart repair) has
become increasingly popular given advancements in surgical technique allowing
for a minimally invasive and reliable improvement in shoulder stability with a
low risk of complication. The high recurrence rate in younger patients may
justify offering surgical treatment after the first dislocation episode. A
recent systematic review by Hurley et al.16 found arthroscopic Bankart repair
resulted in a 7-fold lower recurrence rate and a higher rate of return to sport
and activity than non-operative management21. While other surgical
stabilization options exist, including non-anatomic bony transfer (Latarjet
procedure), the Bankart repair is widespread as it is minimally invasive and
restores native anatomy. Recent data also suggests that patients who are
surgically treated following a FTD have improved outcomes when compared to
those who have recurrent instability events before undergoing surgery.
Delayed management of shoulder instability results in further injury to the
shoulder joint. MRI evaluation of individuals who were assessed greater than 6
months from the time of initial dislocation had increased prevalence of not
only recurrent shoulder instability events but a greater incidence and severity
of intra-articular injury, including SLAP tears, labral tears, and glenoid
cartilage damage.