Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04405947 |
Other study ID # |
2015/7913/I |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 13, 2016 |
Est. completion date |
October 29, 2020 |
Study information
Verified date |
March 2021 |
Source |
Hospital del Mar |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To determine the differences in the placement of the glenoid implant of the inverted
prostheses when they are implanted using a superior approach and using an anterior approach.
Description:
Inverted prostheses have proven to be effective in the treatment of all those pathologies
that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures,
sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous
complications have been described after the use of inverted prostheses, such as glenoid
erosion, infections, dislocation, or aseptic loosening. The most frequent complication
related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of
cases. This complication appears early in the evolution, usually before 2 years after
surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of
long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option
is to place the glenoid component low, so that if the glenoid component is flush with the
lower margin of the glena, the chances of developing glenoid erosion are significantly
reduced. Two types of approaches have been used to implant these prostheses, the
deltopectoral and the superior anterior approach. Each of them has its advantages and
disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors
the best placement of the glenoid component, but sacrifices the subscapularis tendon,
increasing the risk of dislocation of the components. On the contrary, the superior anterior
approach respects the subscapularis tendon, reducing the risk of dislocation of the
components but gives worse surgical exposure.