Comparing the outcomes of non-surgical versus surgical treatment of shoulder fractures with different shoulder replacements
| ISRCTN | ISRCTN85422168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85422168 |
| ClinicalTrials.gov (NCT) | NCT06444828 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IRSTA 123456 |
| Sponsor | Hospital South West Jutland |
| Funder | Hospital South West Jutland |
- Submission date
- 03/07/2021
- Registration date
- 08/07/2021
- Last edited
- 30/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.
Who can participate?
Patients aged above 60 years with complex shoulder fractures
What does the study involve?
Participants are randomly allocated to one of three groups:
Group 1: non-surgical treatment (rehabilitation only)
Group 2: surgical replacement with a 155-degree inclination angle
Group 3: surgical replacement with a 135-degree inclination angle
Participants are followed up after 3, 12 and 24 months. All groups also receive a similar standard rehabilitation program. They have to fill in on questionnaires and measurements of their range of movement and strength will be taken, as well as x-rays.
What are the possible benefits and risks of participating?
There is neither a definite benefit nor risk of participating. All patients who meet the inclusion criteria will be offered the same treatment non-surgical or surgical options, even if they choose not to participate in this study. The treatments are common procedures, the only difference is patients can't choose the treatment.
Where is the study run from?
Hospital South West Jutland (Denmark)
When is the study starting and how long is it expected to run for?
April 2021 to September 2027
Who is funding the study?
Hospital South West Jutland (Denmark)
Who is the main contact?
Dr Klaus Hanisch
klaus.hanisch@rsyd.dk
Contact information
Scientific
Hannevangvej 65
Billum
6852
Denmark
 ORCID ID |
0000-0002-8664-3773 |
|---|---|
| Phone | +45 (0)20535332 |
| klaus.hanisch@rsyd.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized single-blinded controlled study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 40119_PIS.docx |
| Scientific title | Outcome following reverse shoulder arthroplasty for acute proximal humerus fractures with different humerus inclination angles versus non-surgical treatment |
| Study objectives | The aim of the study is to compare the outcomes of different designed reverse shoulder arthroplasty (RSA) versus conservative treatment of proximal humeral fracture (PHF) Neer type III or IV / AO B2, C2. |
| Ethics approval(s) | Approved 01/09/2021, the scientific ethic committee of the region south Denmark (De Videnskabsetiske Komite, Regionshuset, Damhaven 12, 7100, Vejle, Denmark; +45 (0)76638221, +45 (0)29201203; komite@rsyd.dk), ref: 82397 |
| Health condition(s) or problem(s) studied | Proximal humeral fracture type Neer 3 & 4 |
| Intervention | 90 patients are randomized to one of three groups: Group 1: non-surgical treatment (rehabilitation only) Group 2: surgical replacement with a 155-degree inclination angle Group 3: surgical replacement with a 135-degree inclination angle Participants are followed up at 3, 12 and 24 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Measured at 3, 12 and 24 months: |
| Key secondary outcome measure(s) |
Complications and revisions reported in medical records within the 2 years of follow up |
| Completion date | 01/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Proximal humerus fracture type Neer 3 & 4 2. Older than 60 years |
| Key exclusion criteria | 1. Age younger than 60 years 2. Conditions where surgery is mandatory 3. Patients who can't answer questions because of the effects of dementia |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Esbjerg
6700
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Klaus Hanisch (klaus.hanisch@rsyd.dk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 09/10/2024 | 30/12/2024 | Yes | No | |
| Participant information sheet | 04/08/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 04/08/2021 | No | No |
Additional files
- 40119_PROTOCOL.docx
- Protocol file
- 40119_PIS.docx
- Participant information sheet
Editorial Notes
30/12/2024: Publication reference and ClinicalTrials.gov number added.
01/09/2021: The ethics approval was added.
04/08/2021: The protocol and participant information sheet were uploaded as additional files.
06/07/2021: Trial's existence confirmed by the scientific ethic committee of the region south Denmark.
