Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000451808p
Ethics application status
Submitted, not yet approved
Date submitted
4/02/2021
Date registered
19/04/2021
Date last updated
19/04/2021
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Reverse Shoulder Arthroplasty with Augments to Restore Joint Line Anatomy in Patients with Glenoid Bone Loss
Scientific title
Reverse Shoulder Arthroplasty with Augments in Patients with Glenoid Bone Loss (RESHAPING): A Prospective Cohort Study Using Computer Tomography (CT) Scans To Assess Restoration of the Glenohumeral Joint Line Anatomy
Secondary ID [1] 303352 0
Nil
Universal Trial Number (UTN)
Trial acronym
RESHAPING Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glenoid bone loss in patients undergoing reverse shoulder arthroplasty 320617 0
Condition category
Condition code
Surgery 318466 318466 0 0
Other surgery
Musculoskeletal 319189 319189 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective review of hospital records will identify patients who have had metallic augment implants used in their reverse shoulder arthroplasty during the study period. These patients will be contacted for enrolment into the study. There are approximately ~20 patients eligible for enrolment, and all of these patients will be offered enrolment into the study.

NB: All patients who have had reverse shoulder arthroplasty will have had a pre-operative CT scan as part of the standard work up prior to their operation. If there are no pre-operative CT scans available, the patient will be excluded from our study. However, not all patients will have post-operative CT scans.

Once patients have been enrolled, all patients will then undergo a post-surgery CT scan with 3D rendering.

The joint line anatomy will measured on both the pre- and post-operative CT scans, and the differences will be compared. We hypothesise that use of metallic augment can successfully achieve restoration of the patient's pre-operative joint line anatomy.

This will be an observational study. The pre- and post-operative joint line anatomy following metallic augment insertion is what we are observing. The participant must undertake a post-operative CT scan and fill in a one-off questionnaire detailing their function and symptoms. We will use externally validated questionnaires e.g. quick disability of the arm, shoulder and hand score (qDASH). The duration of observation is retrospective and dependent on how long ago they had their metallic augment inserted. The time we expect to be able to perform all CT scans is 6 months.
Intervention code [1] 319665 0
Not applicable
Comparator / control treatment
This is a self-controlled case series.

The patient's joint line anatomy on their pre-operative CT scan is the control group. Following enrolment in the study, they will receive a post-operative CT scan where the joint line anatomy with the metallic augment will be measured, and compared with their pre-operative findings.
Control group
Active

Outcomes
Primary outcome [1] 326431 0
Glenohumeral joint line position post-surgery based on CT scans (pre and post-operative)
Timepoint [1] 326431 0
The primary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. The timepoint is measured from date of surgery to date of post-operative CT scan. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [1] 391471 0
glenoid version on post-operative CT scan images
Timepoint [1] 391471 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. The timepoint is measured from date of surgery to date of post-operative CT scan. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.

To calculate the secondary timepoint, this will be the date of post-operative CT scan minus the date of surgery. We anticipate the approximate mean secondary timepoint is 1 year after surgery.
Secondary outcome [2] 392510 0
base plate inclination on post-operative CT scan images
Timepoint [2] 392510 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. The timepoint is measured from date of surgery to date of post-operative CT scan. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [3] 392511 0
osseous integration on post-operative CT scan images
Timepoint [3] 392511 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. The timepoint is measured from date of surgery to date of post-operative CT scan. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [4] 392512 0
scapular notching on post-operative CT scan images
Timepoint [4] 392512 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. The timepoint is measured from date of surgery to date of post-operative CT scan. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [5] 392513 0
patient reported outcome measures (PROMs). this will be measured with questionnaires such as the qDASH which the patient will complete at the same time as their CT scan.

The qDASH will look at specifically:
- shoulder pain
- neurological symptoms
- how much symptoms interfere with day to day life
- functionality of upper limb with ability to do day to day activities eg. open jar
Timepoint [5] 392513 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. This particular timepoint is measured from date of surgery to date when patient has completed the PROMs questionnaire e.g. qDASH. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [6] 394210 0
Oxford Shoulder Score
- assess pain and functionality of the shoulder
Timepoint [6] 394210 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. This particular timepoint is measured from date of surgery to date when patient has completed the PROMs questionnaire e.g. qDASH. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [7] 394211 0
pain visual analogue scale score
Timepoint [7] 394211 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. This particular timepoint is measured from date of surgery to date when patient has completed the PROMs questionnaire e.g. qDASH. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.
Secondary outcome [8] 394212 0
goniometer measured shoulder range of motion
Timepoint [8] 394212 0
The secondary timepoint is dependent on how long ago the patient had their metallic augment implant inserted. This is variable from patient to patient. This particular timepoint is measured from date of surgery to date when patient has completed the PROMs questionnaire e.g. qDASH. We have excluded all patients within 3 months of their surgery, as we feel this is too soon to provide any meaningful results.

Eligibility
Key inclusion criteria
primary reverse shoulder arthroplasty, metallic augments, patients with glenoid bone loss
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous shoulder surgery, concurrent use of bone graft, CT scan follow up less than 3 months from initial surgery

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
mean and standard deviation calculated for all measurements. inter and intraobserver reliability evaluated using intraclass correlation coefficient

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 23431 0
New Zealand
State/province [1] 23431 0
Northland

Funding & Sponsors
Funding source category [1] 307768 0
Hospital
Name [1] 307768 0
Whangarei Hospital
Country [1] 307768 0
New Zealand
Primary sponsor type
Government body
Name
Northland District Health Board
Address
Whangarei Hospital
Private Bag 9742
Whangarei
0148
Country
New Zealand
Secondary sponsor category [1] 308471 0
None
Name [1] 308471 0
Address [1] 308471 0
Country [1] 308471 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307791 0
New Zealand Health and Disabilities Ethics Committee
Ethics committee address [1] 307791 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 307791 0
New Zealand
Date submitted for ethics approval [1] 307791 0
01/04/2021
Approval date [1] 307791 0
Ethics approval number [1] 307791 0

Summary
Brief summary
Glenoid bone loss is a challenging issue when considering reverse shoulder arthroplasty. The glenoid provides bone stock for fixation of the glenosphere, and any bone loss can affect the position and integrity of the implant. In particular, malposition of the implant due to bone loss can affect the glenohumeral joint line anatomy. Overmedialisation and overlateralisation of the joint line both have their own complications which surgeons must try to avoid. Therefore, restoring the anatomic joint line of the patient in reverse shoulder arthroplasty is paramount to the success of the surgery.

This study aims to investigate whether use of metallic augments in reverse shoulder arthroplasty implants can restore glenohumeral joint line anatomy.

From a single-centred cohort, all patients who have had a primary reverse shoulder arthroplasty and have had pre-operative CT scans will be included in the study. The native joint line will be mapped using 3D reconstruction of the shoulder, and the position of the joint line recorded. Following surgery, post-operative CT scans will be performed and the new joint line anatomy will be measured and compared with pre-operative position. The interval between the two CT scans will vary on the follow up of the patients, but we anticipate a mean follow up period of 2 years.

Study Hypothesis:
In patients with bone loss, we hypothesise that use of metallic augments in reverse shoulder joint replacement surgery can restore the anatomy of the shoulder joint to how it was before surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108506 0
Dr Yushy Zhou
Address 108506 0
Northland District Health Board
Private Bag 9742
Whangarei
0148
Country 108506 0
New Zealand
Phone 108506 0
+64 211367637
Fax 108506 0
Email 108506 0
yzho527@aucklanduni.ac.nz
Contact person for public queries
Name 108507 0
Dr Yushy Zhou
Address 108507 0
Northland District Health Board
Private Bag 9742
Whangarei
0148
Country 108507 0
New Zealand
Phone 108507 0
+64 211367637
Fax 108507 0
Email 108507 0
yzho527@aucklanduni.ac.nz
Contact person for scientific queries
Name 108508 0
Dr Yushy Zhou
Address 108508 0
Northland District Health Board
Private Bag 9742
Whangarei
0148
Country 108508 0
New Zealand
Phone 108508 0
+64 211367637
Fax 108508 0
Email 108508 0
yzho527@aucklanduni.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality will need to be protected as we are using CT images that are patient record linked.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReverse shoulder arthroplasty with metallic augments to preserve bone and restore joint line in patients with glenoid bone loss.2022https://dx.doi.org/10.1053/j.sart.2022.05.001
N.B. These documents automatically identified may not have been verified by the study sponsor.