Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04809077 |
Other study ID # |
S63831 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2021 |
Est. completion date |
April 1, 2024 |
Study information
Verified date |
January 2024 |
Source |
Universitaire Ziekenhuizen KU Leuven |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff
arthropathy. Follow-up has historically focused on the glenoid component because of problems
with fixation and scapular notching leading to functional failure. Since several patients
have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further
research is recommended to evaluate the cause and clinical impact of these radiographic
changes. The goal of this study is to collect long-term radiographic and clinical data in
order to facilitate the identification of risk factors.
Description:
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff
arthropathy. Follow-up has historically focused on the glenoid component because of problems
with fixation and scapular notching leading to functional failure. Fixation of the humeral
component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal
press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to
evaluate and interpret these changes is insufficient at this moment. Since several patients
have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further
research is recommended to evaluate the cause and clinical impact of these radiographic
changes. The goal of this study is to collect long-term radiographic and clinical data in
order to facilitate the identification of risk factors.