The effect of custom-made 3-D printed guides in total shoulder joint replacement
| ISRCTN | ISRCTN12413814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12413814 |
| Secondary identifying numbers | 75988 |
- Submission date
- 29/09/2020
- Registration date
- 28/10/2020
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Orthopedic department
University hospital of Southwest Jutland
Finsenagade 35
Esbjerg
6700
Denmark
 ORCID ID |
0000-0002-9660-6618 |
|---|---|
| Phone | +45 24667485 |
| nwedderkopp@health.sdu.dk |
Study information
| Study design | Single-center double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web-format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | Approved 21/01/2021, Ethics committee of South Denmark (Regionshuset, Damhaven 12, 7100 Vejle, Denmark; no telephone number provided; komite@rsyd.dk), ref: S-20200163 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2019 |
| Completion date | 31/12/2023 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 118 |
| Key inclusion criteria | Shoulder osteoarthritis patients that will receive a shoulder arthroplasty |
| Key exclusion criteria | 1. Hypoplasia 2. Severe osteoarthritis requiring a custom made guide under all circumstances |
| Date of first enrolment | 14/06/2021 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Finsensgade 35
Esbjerg
6700
Denmark
Sponsor information
University/education
WInsloewparken 19
Odense C
5100
Denmark
| Phone | +45 6550 3828 |
|---|---|
| sterp@health.sdu.dk | |
| Website | https://www.sdu.dk/en/om_sdu/institutter_centre/irs_regional_sundhedsforskning |
"ROR" |
https://ror.org/03yrrjy16 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plan to publish the results in The Journal of Shoulder and Elbow Surgery. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Editorial Notes
01/02/2022: The study was stopped due to staff issues.
14/06/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2021 to 14/06/2021.
2. The ethics approval was added.
04/01/2021: The recruitment start date was changed from 01/01/2021 to 01/04/2021.
14/10/2020: Trial’s existence confirmed by Region Syddanmark
