Placement of shoulder replacement for complex upper arm fractures
| ISRCTN | ISRCTN28175069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28175069 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Tianjin Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 12/02/2020
- Registration date
- 21/04/2020
- Last edited
- 20/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The proximal fracture of the humerus (where the upper arm joins the shoulder) is one of the most common fractures in elderly patients. The placement of shoulder prosthesis used for reconstruction of a complex proximal humerus fractures is challenging. To achieve the anatomical placement of prosthesis, the researchers introduced a new operative technique to determine the humerus height and humeral head retroversion. Herein, the researchers retrospectively investigated the clinical and radiographic outcomes of our procedure
Who can participate?
Patients treated by shoulder arthroplasty for proximal humeral fracture during the period between June 2016 and December 2018.
What does the study involve?
34 patients, treated by shoulder arthroplasty for 4-part or 3–part proximal humeral fracture during the period between June 2016 and December 2018, were enrolled in the study. Patients treated with classic method were compared to patients treated with the new method treated patients by operation time, blood loss, pain, range of motion, Constant-Murley score and radiologic features.
What are the possible benefits and risks of participating?
None (retrospective study).
Where is the study run from?
Tianjin Hospital (China)
When is the study starting and how long is it expected to run for?
June 2016 to December 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Jian'an Li
jianan12210@163.com
Contact information
Scientific
Tianjin Hospital
Jie Fang Rd. 406
Tianjin
300211
China
 ORCID ID |
0000-0002-0894-4060 |
|---|---|
| Phone | +86 18202536717 |
| jianan12210@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational study |
| Secondary study design | Nested case-control study |
| Study type | Participant information sheet |
| Scientific title | Anatomic placement of shoulder prosthesis for complex proximal humerus fractures |
| Study objectives | The placement of shoulder prosthesis used for reconstruction of a complex proximal humerus fractures is challenging. To achieve the anatomical placement of prosthesis, we introduced a new operative technique to determine the humerus height and humeral head retroversion. Herein, we retrospectively investigated the clinical and radiographic outcomes of our procedure. |
| Ethics approval(s) | Approved 03/03/2020, Ethics committee of Tianjin Hospital (Jiefang Rd. 406, TianJin, China, 300202; +86 (0)22-60910673), ref: daibincn@sina.com |
| Health condition(s) or problem(s) studied | Proximal fracture of humerus |
| Intervention | The patients were treated with classic method during the period between June 2016 and August 2017. The surgeons involved in this study stopped using this method and switched to our modified method from September 2017 to December 2018. Herein, we retrospectively investigated the clinical and radiographic outcomes of the two procedures. The total duration of follow-up was set as the period between operation and last follow-up. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Overall shoulder function measure using the constant-Murley score at the last follow up appointment |
| Key secondary outcome measure(s) |
1. Shoulder pain measured using Visual Analog scale at follow up appointments |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | Patients treated by shoulder arthroplasty for proximal humeral fracture during the period between June 2016 and December 2018 |
| Key exclusion criteria | The patients can not be followed up. |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- China
Study participating centre
Tianjin
300211
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/04/2020: Trial’s existence confirmed by the ethics committee of Tianjin Hospital.
