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 number | NCT06444828 |
| Secondary identifying numbers | IRSTA 123456 |
- Submission date
- 03/07/2021
- Registration date
- 08/07/2021
- Last edited
- 30/12/2024
- Recruitment status
- 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
| Study design | Randomized single-blinded controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Measured at 3, 12 and 24 months: 1. Quality of life measured using the Western Ontario Osteoarthritis score (WOOS) 2. Pain, activities of daily living, range of movement and strength measured by specially trained physiotherapists with the Constant Murley (CS) score 3. Quality of life measured using the Subjective Shoulder Value (SSV) questionnaire 4. Bone healing response evaluated using x-ray as union/non-union/pseudarthrosis in the non-surgical group and status of healing of the tuberosities as healed, displaced over 5 mm or resorbed |
| Secondary outcome measures | Complications and revisions reported in medical records within the 2 years of follow up |
| Overall study start date | 01/04/2021 |
| Completion date | 01/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Hospital/treatment centre
c/o Christina Staal
Orthopedic Department
Finsengade 35
Esbjerg
6700
Denmark
| Phone | +45 (0)79182111 |
|---|---|
| Christina.Staal@rsyd.dk | |
| Website | https://www.sydvestjysksygehus.dk |
"ROR" |
https://ror.org/03pzgk858 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed international journal |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | 04/08/2021 | No | Yes | ||
| Protocol file | 04/08/2021 | No | No | ||
| Protocol article | 09/10/2024 | 30/12/2024 | Yes | No |
Additional files
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.
