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Trial registered on ANZCTR


Registration number
ACTRN12616000864426
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
1/07/2016
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stability, functional and clinical outcomes following Reverse Total Shoulder Arthroplasty (RSA); Repair versus Non-Repair of the Subscapularis
Scientific title
Stability, functional and clinical outcomes following Reverse Total Shoulder Arthroplasty (RSA); Repair versus Non-Repair of the Subscapularis
Secondary ID [1] 289475 0
None
Universal Trial Number (UTN)
U1111-1184-3618
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of the subscapularis following reverse total shoulder arthroplasty 299160 0
arthritis 299161 0
Condition category
Condition code
Musculoskeletal 299177 299177 0 0
Osteoarthritis
Surgery 299178 299178 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing Reverse Shoulder Arthroplasty (RSA) using the deltopectoral approach require the release of the subscapularis either via tenotomy or lesser tuberosity osteotomy. The importance of the subscapularis in patients with a RSA prosthesis and consequently, the need of repair following implantation, remains controversial.

The exposure of interest is Subscapularis repair compared to non-repair following RSA.

The duration of follow-up period is designed for a single assessment session in which the clinical, functional and radiographic assessments will be conducted. Assessments will require approximately two hours to complete, occurring at any point between surgery and 5 years post surgery. The two hours may be spread of over multiple visits depending on the participant's and health professionals availability.
Intervention code [1] 295064 0
Not applicable
Comparator / control treatment
This study will compare stability, functional and clinical outcomes of a repaired versus non-repaired/irreparable Subscapularis following reverse shoulder arthroplasty.
Control group
Active

Outcomes
Primary outcome [1] 298659 0
To assess the difference in the function, as measured by the self-reported ASES score, between two RSA treatment groups up to 5 years post-surgery.
Timepoint [1] 298659 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [1] 324867 0
To compare outcomes of patients implanted with a medialised versus lateralised Reverse Total Shoulder prosthesis between the two treatment groups.

A CT-scan will be conducted to measure the extent of lateralisation, achieved by the use of a lateralised prosthesis.
Timepoint [1] 324867 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [2] 324868 0
To consider the influence of scar tissue development on functional and clinical outcomes between the two treatment groups.

Scar tissue development will be assessed using Ultrasonography.
Timepoint [2] 324868 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [3] 324881 0
To assess the patient-reported shoulder function following RSA without repair of the subscapularis compared to RSA with repair of the subscapularis.

This will be measured using American Shoulder and Elbow Surgeons Questionnaire patient-reported outcome measure.


Timepoint [3] 324881 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [4] 324883 0
To assess the patient-reported quality of life following RSA without repair of the subscapularis compared to RSA with repair of the subscapularis.

This will be measured using the Euroqol 5 Dimensional Health Survey (EQ-5D-5L) patient reported outcome measure.

Timepoint [4] 324883 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [5] 324884 0
To assess patient-reported shoulder instability following RSA without repair of the subscapularis compared to RSA with repair of the subscapularis.

This will be measured using the Western Ontario Shoulder Instability Index (WOSI) patient reported outcome measure.


Timepoint [5] 324884 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [6] 324887 0
To assess the patient-reported symptoms and function following RSA without repair of the subscapularis compared to RSA with repair of the subscapularis.

This will be measured using the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) outcome measures.
Timepoint [6] 324887 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [7] 324889 0
To assess the patient's perception of recovery following RSA without repair of the subscapularis compared to RSA with repair of the subscapularis.

This will be measured using the Patient perceived rate of recovery patient-reported outcome measure.

Timepoint [7] 324889 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [8] 324891 0
Evaluate the intra- and inter-rater reliability of range of motion (ROM), manual muscle testing (MMT) and hand held dynamometry (HHD) strength testing for assessment of Reverse Total Shoulder Arthroplasty patients.
Timepoint [8] 324891 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.
Secondary outcome [9] 325189 0
To assess the extent of internal impingement, fatty infiltration of the rotator cuff and presence of an acromial fracture (composite). Such factors will be measured using a CT-scan and compared between the 2 study groups.
Timepoint [9] 325189 0
Single time-point between 0 and 5 years post reverse total shoulder replacement.

Eligibility
Key inclusion criteria
Patient has provided written, informed consent and is willing to participant.
Participant is a male or non-pregnant female, at least 40 years old, and preferably at least 50 years of age.
Patient has received a Reverse Total Shoulder Replacement implanted within the previous 5 years.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has undergone Revision reverse shoulder arthroplasty (i.e. previous resurfacing, hemi, total or reverse).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A total sample of 56 participants achieves 80% power to detect a difference of at least 9.70 using a two independent samples t-test at a 0.0500 significance level. The common standard deviation within a group is assumed to be 12.7.

Repeated strength and range of motion measures will be performed on a convenience sub-sample of 20 RSA subjects in order to consider intra- and inter-rater reliability of MMT, HHD and ROM in the functional assessment of RSA subjects.

Statistical analyses that will be undertaken to assess study objectives will be a two independent samples t-test, conditional on fulfilling test assumptions. If study data produced results in violation of test assumptions of the two independent samples t-test, alternative testing may include non-parametric equivalence of this t-test.

The two independent samples t-test can be controlled for some of the variants that may confound study results. Such variants may include a difference in prostheses implanted or in the mean follow-up between receiving the surgical procedure and post-operative time of recall. An analysis technique may be required to assess the group means while controlling for such aforementioned confounding variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5992 0
Southern Adelaide Health Institute - Belair

Funding & Sponsors
Funding source category [1] 293838 0
Other
Name [1] 293838 0
The International Musculoskeletal Research Institute Inc.
Address [1] 293838 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Rd,
Belair, SA 5052
Country [1] 293838 0
Australia
Primary sponsor type
Individual
Name
Professor Jeganath Krishnan
Address
Professor Jegan Krishnan
13 Laffers Rd,
Belair, SA 5052
Country
Australia
Secondary sponsor category [1] 292672 0
Other Collaborative groups
Name [1] 292672 0
The International Musculoskeletal Research Institute
Address [1] 292672 0
13 Laffers Rd,
Belair, SA 5052
Country [1] 292672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295266 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 295266 0
Flinders Medical Centre/The Flats F6/F8
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 295266 0
Australia
Date submitted for ethics approval [1] 295266 0
06/11/2015
Approval date [1] 295266 0
13/05/2016
Ethics approval number [1] 295266 0
460.15

Summary
Brief summary
The importance of the subscapularis in patients with a Reverse Shoulder Arthroplasty prosthesis and consequently, the need of repair following implantation, remains controversial. The aim of the study is to determine the stability, functional and clinical outcomes of a repaired versus non-repaired/irreparable subscapularis following Reverse Total Shoulder Arthroplasty.

The primary objective of this study is to assess the difference in the function, as measured by the self-reported ASES score, between two RSA treatment groups up to 5 years post-surgery.

Secondary objectives are to:

Compare outcomes of patients implanted with a medialised versus lateralised Reverse Total Shoulder prosthesis between the two treatment groups.

Consider the influence of scar tissue development on functional and clinical outcomes between the two treatment groups.

A physiotherapy focused substudy will evaluate the intra- and inter-rater reliability of range of motion (ROM), manual muscle testing (MMT) and hand held dynamometry (HHD) strength testing for assessment of Reverse Total Shoulder Arthroplasty patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66726 0
Prof Jeganath Krishnan
Address 66726 0
Professor Jegan Krishnan
13 Laffers Road,
Belair, SA 5052
Country 66726 0
Australia
Phone 66726 0
+618 8267 8233
Fax 66726 0
Email 66726 0
krishnanadmin@sahi.org.au
Contact person for public queries
Name 66727 0
Ms Annika Theodoulou
Address 66727 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Road,
Belair, SA 5052,
Country 66727 0
Australia
Phone 66727 0
+61 8 7231 8452
Fax 66727 0
Email 66727 0
Annika.Theodoulou@imri.org.au
Contact person for scientific queries
Name 66728 0
Prof Jeganath Krishnan
Address 66728 0
Professor Jegan Krishnan
13 Laffers Road,
Belair, SA 5052
Country 66728 0
Australia
Phone 66728 0
+618 8267 8233
Fax 66728 0
Email 66728 0
krishnanadmin@sahi.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary