Plain English Summary
Background and study aims
The shoulder is a ball and socket-type joint made up of two main parts: the glenoid (socket) and the humerus (upper arm bone, which makes up the ball). It is therefore known as the gleno-humeral joint. When arthritis affects the shoulder it causes the lining of these joint surfaces to wear, causing pain and stiffness. During a total shoulder replacement (arthroplasty), both the head of the humerus and the socket are replaced with artificial surfaces (metal and plastic).
Reducing operation time and being more precise in the insertion of the arthroplasty should in theory provide better outcomes and fewer failures. The aim of this study is to assess the effect of the use of three-D printed custom-made guides for the placement of the glenoid part of the arthroplasty.
Who can participate?
Patients receiving an offer of a shoulder arthroplasty to treat their shoulder osteoarthritis will be asked to participate in the study.
What does the study involve?
Participants will be randomly allocated to receive shoulder replacement with or without the use of a custom made guide.
What are the possible benefits and risks of participating?
Benefits could be better movement of the shoulder, better placement and longer survival of the arthroplasty.
The use of “custom-made guides” for operation is not in any way expected to introduce new risk or aggravate the already existing risks of a shoulder arthroplasty operation.
Where is the study run from?
Orthopedic Department, University Hospital of Southwest Jutland (Denmark)
When is the study starting and how long is it expected to run for?
October 2019 to December 2023
Who is funding the study?
1. Innovation foundation of the Region of South Denmark
2. Orthopedic Department, University Hospital of Southwest Jutland, Denmark
Who is the main contact?
Prof. Niels Wedderkopp, nwedderkopp@health.sdu.dk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Niels Wedderkopp
ORCID ID
http://orcid.org/0000-0002-9660-6618
Contact details
Orthopedic department
University hospital of Southwest Jutland
Finsenagade 35
Esbjerg
6700
Denmark
+45 24667485
nwedderkopp@health.sdu.dk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
75988
Study information
Scientific title
The effect of custom-made 3-D printed guides for insertion of the glenoid part in total shoulder arthroplasty. A prospective randomized study
Acronym
Study hypothesis
To assess the effect of the use of 3D printed custom-made guides for the placement of the glenoid part of the arthroplasty. A custom-made guide should 1. Shorten the operating time, 2. Make the placement more precise, and through these improvements make the patient less prone to complications like infections and dislocations.
Ethics approval
Approval pending, Ethics committee of South Denmark
Study design
Single-center double-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web-format, please use contact details to request a participant information sheet.
Condition
Shoulder osteoarthritis
Intervention
The participants will be randomly put into two groups (block randomization with four subjects in each block using STATA 16 MP):
The intervention group will have 3D printed custom-made guides used for the placement of the glenoid part of shoulder arthroplasty.
The control group will have the traditional surgery without custom made guide.
The two groups will followed-up using Patient Reported Outcome Measures (PROMs) and CT-scans. The PROMs will be administered at baseline, and at 3,6 and 12 months postoperatively. In addition, the patients will be followed with "momentary assessment" questionnaires every week to assess the trajectories of the rehabilitation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Self-reported shoulder function measured using The Western Ontario Osteoarthritis of the Shoulder index at baseline, 3, 6, 12 and 24 months follow-up
2. Level of activity measured using the Constant-Murley score (by a physiotherapist) at baseline, 3, 6, 12 and 24 months follow-up
3. Self-reported pain level using numeric rating scale reported weekly by SMS
Secondary outcome measures
Placement of the arthroplasty assessed using a CT-scan at 12 months
Overall trial start date
01/10/2019
Overall trial end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Shoulder osteoarthritis patients that will receive a shoulder arthroplasty
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
118
Participant exclusion criteria
1. Hypoplasia
2. Severe osteoarthritis requiring a custom made guide under all circumstances
Recruitment start date
01/01/2021
Recruitment end date
31/12/2021
Locations
Countries of recruitment
Denmark
Trial participating centre
University Hospital of Southwest Jutland
Orthopedic department
Finsensgade 35
Esbjerg
6700
Denmark
Sponsor information
Organisation
University of Southern Denmark
Sponsor details
WInsloewparken 19
Odense C
5100
Denmark
+45 6550 3828
sterp@health.sdu.dk
Sponsor type
University/education
Website
https://www.sdu.dk/en/om_sdu/institutter_centre/irs_regional_sundhedsforskning
Funders
Funder type
Government
Funder name
Innovation foundation of the Region of South Denmark
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Orthopedic dep. University Hospital of Southwest Jutland, Denmark.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to publish the results in The Journal of Shoulder and Elbow Surgery.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
01/06/2024
Participant level data
Available on request
Basic results (scientific)
Publication list