Condition category
Musculoskeletal Diseases
Date applied
12/02/2020
Date assigned
21/04/2020
Last edited
20/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jian'an Li

ORCID ID

http://orcid.org/0000-0002-0894-4060

Contact details

Tianjin Hospital
Jie Fang Rd. 406
Tianjin
300211
China
+86 18202536717
jianan12210@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Anatomic placement of shoulder prosthesis for complex proximal humerus fractures

Acronym

Study hypothesis

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

Approved 03/03/2020, Ethics committee of Tianjin Hospital (Jiefang Rd. 406, TianJin, China, 300202; +86 (0)22-60910673), ref: daibincn@sina.com

Study design

Retrospective observational study

Primary study design

Observational

Secondary study design

Nested case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measure

Overall shoulder function measure using the constant-Murley score at the last follow up appointment

Secondary outcome measures

1. Shoulder pain measured using Visual Analog scale at follow up appointments
2. ROM of shoulder measured at follow up appointments
3. Radiologic outcomes (anteroposterior, scapular Y, and axillary views, and the status of tuberosities is defined as healing, malunion, migration, and resorption) measured at follow up appointments

Overall trial start date

01/10/2019

Overall trial end date

01/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients treated by shoulder arthroplasty for proximal humeral fracture during the period between June 2016 and December 2018

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Total final enrolment

34

Participant exclusion criteria

The patients can not be followed up.

Recruitment start date

01/06/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

China

Trial participating centre

Tianjin Hospital
Jie Fang Rd. 406
Tianjin
300211
China

Sponsor information

Organisation

Tianjin Hospital

Sponsor details

Jie Fang Rd. 406
Tianjin
300211
China
+86 2260910608
181974183@qq.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

BMC musculoskeletal disorders.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/03/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/04/2020: Trial’s existence confirmed by the ethics committee of Tianjin Hospital.