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Trial registered on ANZCTR

Registration number

ACTRN12620000016932

Ethics application status

Approved

Date submitted

3/12/2019

Date registered

14/01/2020

Date last updated

2/03/2023

Date data sharing statement initially provided

14/01/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating the effects of shoulder stabilisation procedures on shoulder joint function

Scientific title

A single-centre, parallel-arm trial evaluating the effects of arthroscopic Bankart repair and open Latarjet shoulder stabilisation procedures on shoulder joint neuromechanics and function

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1230-1812

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder instability

Condition category

Condition code

Surgery

Surgical techniques

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants in the experimental groups will undergo shoulder stabilisation either via an arthroscopic Bankart repair (Arm 1) or an open Latarjet (Arm 2) procedure. The procedures differ in the method with which the surgery is performed (i.e. arthroscopic vs. open) and the manner with which the joint is reconstructed (i.e. anatomical vs. non-anatomic). One of three fellowship trained orthopaedic surgeons will conduct each surgical procedure. The decision as to what stabilisation procedure participants in the experimental group undergoes will be determined by consultation between the individual and the acting surgeon. Fidelity of the procedures will be monitored through surgical notes, reviewing medical images post-surgery, and clinical observation.

Arm 1 - Arthroscopic Bankart Repair
Individuals will be evaluated under anaesthetic to determine the stability pattern of the glenohumeral joint, with clinical findings considered alongside pre-operative medical images. The joint space will be accessed with arthroscopic portals. The glenohumeral labral tear will be prepared with liberator probes and shaver, and capsulolabral reduction and fixation anteriorly and/or posteriorly will occur with anchors according to the injury pattern. Procedure duration will be approximately 60 minutes.

Arm 2 - Open Latarjet
An oblique three to five centimetre incision will be made under anaesthesia from the tip of the coracoid process and extending inferiorly down the deltopectoral groove to the superior portion of the axillary fold. A 22 to 27 millimetre bone graft will be harvested from the tip of the coracoid process, with harvesting and preparation of the graft performed according to standardised procedures and ensuring that the graft is shaped to be flush with the anterior face of the glenoid. The anterior portion of the shoulder will be exposed by dividing the subscapularis in line with the muscle fibres, maintaining a 50-50 split of the upper and lower portions of the muscle. A T-shaped incision will be made in the labrum at the apex of the bony deformity in preparation to set the coracoid bone graft in place. The coracoid bone graft will be positioned so that it serves as an extension of the inherent articular arc of the glenoid. Once the ideal position is identified, fixation of the bone graft to the anterior glenoid will be achieved via two surgical screws. Anchors will be placed in the native glenoid and the joint capsule repaired. The subscapularis will be repaired over the coracoid bone graft, with the conjoint tendon exiting anteriorly through the previously split segments of the subscapularis. Procedure duration will be approximately 90 minutes.

Postoperative Patient Care
Irrespective of the surgical procedure they undergo will follow the clinics standardised protocols and care pathways. Participants will use an immobiliser sling for at least four weeks post-surgery and then commence a rehabilitation program to improve active shoulder stability. Progressive increases to range of movement exercises, strengthening and functional restoration will be incorporated into each participant’s individualised program. Rehabilitation will be monitored by the clinic for at least three months postoperatively. In addition, the number of training sessions the individual completes during the six-month period following surgery will be monitored via an online survey. Specifically, participants will be prompted to complete an online survey detailing the number and type (i.e. range of motion, strength or functional movement) of training sessions they have completed over the past two weeks. This survey will take approximately 3-5 minutes to complete each fortnight. Return to sport will be recommended after six-months, pending the participant’s recovery. Participants in the control group will be instructed to continue their regular training over the study period.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Rehabilitation

Comparator / control treatment

Participants with no history of shoulder instability injury or reported perceived symptoms of shoulder instability as deemed by the Oxford Instability Score questionnaire; no prior history of upper limb reconstructive surgery; and no known neurological condition affecting the upper limb will act as controls.

Control group

Active

Outcomes

Primary outcome [1]

A composite measure of glenohumeral stability during activities of daily living as assessed by the direction of the glenohumeral joint reaction force vector in the scapula plane. Three-dimensional (3D) kinematics and kinetics of the shoulder will be collected using a 3D motion capture system (Vicon, Oxford, United Kingdom) and examined during select activities of daily living. The activities of daily living will include a forward reach, upward reach to shoulder height and above horizontal, axilla wash, rear torso reach, and hair comb. Glenohumeral joint reaction forces will be calculated from muscle-driven simulations of the tasks using a scaled upper-limb musculoskeletal model. Glenohumeral stability across the movement tasks examined will be estimated using the direction of the glenohumeral joint reaction force vector in the scapula plane. The stability of the joint will be defined as a function of the angle of the resultant joint reaction force vector in the glenoid relative to the maximum angle required to reach the outer edge of the glenoid.

Timepoint [1]

1-week pre-surgery and 6-months post-surgery

Primary outcome [2]

Glenohumeral stability during an overhead sporting task as assessed by the direction of the glenohumeral joint reaction force vector in the scapula plane. The overhead sporting task will consist of a run-up and jump to reach a ball, replicating a task that uses the shoulder joint in a typical sporting environment. The measurement of this outcome will be identical to that outlined in primary outcome 1.

Timepoint [2]

1-week pre-surgery and 6-months post-surgery

Primary outcome [3]

A composite measure of shoulder joint neuromechanics (i.e. kinematics and kinetics) during the activities of daily living and an overhead sporting task as assessed by three-dimensional motion capture and musculoskeletal modelling. Kinematic and kinetic components assessed will include shoulder joint angles (i.e. shoulder elevation angle, shoulder elevation plane, shoulder rotation angle) and external shoulder joint moments (i.e. shoulder elevation torque, shoulder rotation torque), respectively. Kinematic and kinetic measurements will be assessed as per the methods outlined in primary outcome 1 (i.e. three-dimensional motion capture).

Timepoint [3]

1 week pre-surgery and 6-months post-surgery

Secondary outcome [1]

A composite of isometric shoulder muscle strength will be measured in the directions of adduction, flexion and external/internal rotation, using an isokinetic dynamometer.

Timepoint [1]