Condition category
Musculoskeletal Diseases
Date applied
29/09/2020
Date assigned
28/10/2020
Last edited
28/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Publication citations

Additional files

Editorial Notes

14/10/2020: Trial’s existence confirmed by Region Syddanmark