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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] 297724 0
None
Universal Trial Number (UTN)
U1111-1230-1812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder instability 312051 0
Condition category
Condition code
Surgery 310613 310613 0 0
Surgical techniques
Injuries and Accidents 310614 310614 0 0
Other injuries and accidents
Musculoskeletal 310615 310615 0 0
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] 313966 0
Treatment: Surgery
Intervention code [2] 316327 0
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] 319466 0
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] 319466 0
1-week pre-surgery and 6-months post-surgery
Primary outcome [2] 322253 0
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] 322253 0
1-week pre-surgery and 6-months post-surgery
Primary outcome [3] 322491 0
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] 322491 0
1 week pre-surgery and 6-months post-surgery
Secondary outcome [1] 368277 0
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] 368277 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [2] 368278 0
A composite of eccentric isokinetic strength will be assessed in the directions of flexion and external/internal rotation, in postures associated with anterior instability injuries in contact sport athletes, using an isokinetic dynamometer.
Timepoint [2] 368278 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [3] 368280 0
Abduction range of motion of the shoulder joint will be assessed using an isokinetic dynamometer.
Timepoint [3] 368280 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [4] 377885 0
Flexion range of motion of the shoulder joint will be assessed using an isokinetic dynamometer.
Timepoint [4] 377885 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [5] 377886 0
Extension range of motion of the shoulder joint will be assessed using an isokinetic dynamometer.
Timepoint [5] 377886 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [6] 378696 0
External rotation range of motion of the shoulder joint will be assessed using an isokinetic dynamometer.
Timepoint [6] 378696 0
1 week pre-surgery and 6 months post-surgery
Secondary outcome [7] 378697 0
Self-reported shoulder function will be assessed via the Oxford Instability Score (OIS) and the Melbourne Instability Shoulder Scale (MISS),
Timepoint [7] 378697 0
1 week pre-surgery, and 3 months, 6 months and 12 months post-surgery
Secondary outcome [8] 378698 0
General health status will be assessed via the EQ-5D-5L.
Timepoint [8] 378698 0
1 week pre-surgery, and 3 months, 6 months and 12 months post-surgery

Eligibility
Key inclusion criteria
1. Currently or recently (past 12 months) engaged in an overhead contact sport (i.e. Australian Rules Football, American Football, Rugby League or Union, Lacrosse)
2. Experienced one or more traumatic shoulder instability injury (i.e. subluxation or dislocation) resulting in a surgical stabilisation procedure being required (experimental groups only)
3. Willing, able and mentally competent to provide informed consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior history of shoulder instability injury or reported perceived symptoms of shoulder instability as deemed by the Oxford Instability Score questionnaire.
2. Prior history of upper limb reconstructive surgery.
3. Known neurological condition affecting the upper limb.
4. Presence of adhesive capsulitis of the shoulder.
5. Presence of a larger rotator cuff tear as determined via magnetic resonance imaging.
6. Contraindications for undergoing magnetic resonance imaging (e.g. metallic foreign bodies, heart pacemakers).
7. Foreseeable circumstances that will result in the participant being unavailable for the 12-month follow-up period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on the primary outcome of glenohumeral stability. To our knowledge, no specific data pertaining to the metric of glenohumeral stability is available for individuals following shoulder stabilisation surgery; nor is there any indication in the literature as to what is deemed to be a clinically important difference for this metric. As such, sample size calculations are based on data presented in Marchi et al 2014 (Med Biol Eng Comput, 52: 251-256), which examined glenohumeral stability in individuals with a history of shoulder joint dislocation during hand-positioning tasks. Mean and standard deviation in this existing study for glenohumeral stability was 0.655 ± 0.023. We have assumed a conservative change of 5% (i.e. 0.033) to represent a clinically important difference. Based on this difference, a sample size of 27 participants (i.e. nine per group) is calculated with a power (1-ß) of 80% and a type I error (a) of 5%. This trial will therefore include a total of 30 participants (10 per group) to meet the computed sample size while allowing for 10% dropout. To compensate for any potential insufficiencies in our a priori sample size calculation (due to lack of comparable studies), we will perform post-hoc power calculations to evaluate any beta error. Additionally, all differences will be presented and interpreted with 95% confidence intervals and effect size estimates.

Data will be compared across groups and time-points using a two-way (group x time) analysis of variance (ANOVA) with repeated measures on one factor (i.e. time) design, or the non-parametric equivalent should data not be normally distributed (as assessed by a Shapiro-Wilk test). The discrete outcome measures of glenohumeral joint stability, shoulder strength, shoulder range of motion, and self-report measure scores will be submitted to a traditional ANOVA using the aforementioned design. The continuous outcome measures of joint kinematics and moments, muscle activations and forces, and joint reaction forces will be submitted to an equivalent ANOVA design using vector-field one-dimensional statistical parametric mapping (SPM1D). Relevant post-hoc comparisons (with Bonferroni corrections applied) will be made between groups and time-points where ANOVA detects a statistically significant different (p < 0.05 adjusted for the multiple comparisons made). 95% confidence intervals and estimates of effect sizes (i.e. Cohen’s d) will also be calculated for differences between- and within-groups across the time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302253 0
University
Name [1] 302253 0
Deakin University
Country [1] 302253 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Bellarine Street, Geelong, Victoria, Australia, 3220
Country
Australia
Secondary sponsor category [1] 302112 0
University
Name [1] 302112 0
Deakin University
Address [1] 302112 0
75 Pigdons Road, Waurn Ponds, 3216, Victoria, Australia
Country [1] 302112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302928 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 302928 0
Ethics committee country [1] 302928 0
Australia
Date submitted for ethics approval [1] 302928 0
24/04/2019
Approval date [1] 302928 0
24/10/2019
Ethics approval number [1] 302928 0
19/53
Ethics committee name [2] 302940 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 302940 0
Ethics committee country [2] 302940 0
Australia
Date submitted for ethics approval [2] 302940 0
31/10/2019
Approval date [2] 302940 0
04/11/2019
Ethics approval number [2] 302940 0
2019-419

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91878 0
Prof Richard Page
Address 91878 0
Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
Country 91878 0
Australia
Phone 91878 0
+61 3 5222 5777
Fax 91878 0
Email 91878 0
richard.page@deakin.edu.au
Contact person for public queries
Name 91879 0
Aaron Fox
Address 91879 0
Centre for Sports Research, School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road, Waurn Ponds, 3216, Victoria, Australia
Country 91879 0
Australia
Phone 91879 0
+61 3 5247 9720
Fax 91879 0
Email 91879 0
aaron.f@deakin.edu.au
Contact person for scientific queries
Name 91880 0
Aaron Fox
Address 91880 0
Centre for Sports Research, School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road, Waurn Ponds, 3216, Victoria, Australia
Country 91880 0
Australia
Phone 91880 0
+61 3 5247 9720
Fax 91880 0
Email 91880 0
aaron.f@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for individual participant data sharing was not obtained.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the effects of arthroscopic Bankart repair and open Latarjet shoulder stabilisation procedures on shoulder joint neuromechanics and function: A single-centre, parallel-arm trial protocol.2021https://dx.doi.org/10.1136/bmjsem-2020-000956
N.B. These documents automatically identified may not have been verified by the study sponsor.