Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06154694 |
| Other study ID # |
S64986 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2021 |
| Est. completion date |
July 1, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Filip Verhaegen |
| Phone |
+32 16 33 88 27 |
| Email |
filip.verhaegen[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Shoulder osteoarthritis (OA) is a frequent problem in our aging population and is believed to
occur in up to 20% of the population. Different types of glenoid morphology are associated
with shoulder OA, depending on the amount and localization of the glenoid erosion as well as
the amount and direction of Humeral Head Migration.
Total shoulder arthroplasty (TSA) has been shown to relieve the pain and improve joint
function of patients with OA. However, several complications such as component loosening and
polyethylene damage has been reported and it has been revealed that 7.3% of glenoids may show
signs of asymptomatic radiographic loosening annually after primary anatomic TSA. The
mechanism of such fixation failure is still unclear.
The main goal of this study is evaluating in-vivo glenohumeral contact patterns in patients
with osteoarthritic glenoids before and after TSA, to unravel the high rate of glenoid
component loosening.
Description:
Shoulder osteoarthritis (OA) is a frequent problem in our aging population and is believed to
occur in up to 20% of the population. OA leads to pain, restriction of movement and
functional disability. Furthermore, chronic instability, characterized by humeral head
migration (HHM), and pathologic changes of the glenoid bone, i.e. glenoid erosions, is common
in OA. Different types of glenoid morphology are associated with shoulder OA, depending on
the amount and localization of the glenoid erosion as well as the amount and direction of
HHM. On the basis of these factors glenoids are classified in A, B, C and D types 4. In this
classification A glenoid is a centered or symmetric arthritis without posterior subluxation
of the humeral head. The B glenoid is characterized by asymmetric bone erosion, leading to
glenoid retroversion, combined with posterior HHM. The D glenoid is defined by glenoid
anteversion or anterior humeral head subluxation, while C glenoid is a dysplastic glenoid
with at least 25° of retroversion "not caused by erosion.
Total shoulder arthroplasty (TSA) has been shown to relieve the pain and improve joint
function of patients with OA. However, several complications such as component loosening and
polyethylene damage has been reported and it has been revealed that 7.3% of glenoids may show
signs of asymptomatic radiographic loosening annually after primary anatomic TSA. Although,
aberrant glenohumeral contact mechanics has been suggested to be one of the primary potential
causes, the mechanism of such fixation failure is still unclear. Glenohumeral conformity,
eccentric loads associated with shoulder instability, bone quality, cementing techniques,
implant orientation and design are all confounding factors that indeed affect the mechanical
environment of the glenoid component, and, more specifically, also in terms of the contact
mechanics.
Knowledge of in vivo glenohumeral joint contact mechanics before and after total shoulder
arthroplasty and its interplay with patient- and surgery-related parameters may unravel the
high rate of glenoid component loosening in patients with osteoarthritic glenoids and provide
insight for the improvement of patient function, implant designs, implant longevity, and
surgical technique. Previous ex-vivo and computational modelling studies that focused on the
glenohumeral contact area after TSA, suggested that arm elevation in the scapular plane
results in aberrant posterior translation of the humeral head in TSA patients. However, an
in-vivo study based on dual-plane fluoroscopy, demonstrated that this only occurs in 50% of
TSA patients. These discrepancies could arise from analyzing an assorted population of TSA
patients without taking into account any specific information with regards to their
preoperative osseous and soft-tissue status such as type of glenoid erosion, degree of
glenoid retroversion, and amount of rotator cuff degeneration. Postoperative factors such as
degree of retroversion correction, amount of joint-line medialization and glenohumeral
components' radial mismatch were also not considered in these studies.
The main goal of this study is evaluating in-vivo glenohumeral contact patterns in patients
with osteoarthritic glenoids before and after TSA, to unravel the high rate of glenoid
component loosening. To that aim, the project is divided into four sub-objectives. The first
objective is to compare glenohumeral contact areas before and after surgery in patients with
osteoarthritic glenoids, using EOS (micro-dose x-ray) stereo radiographic imaging, to
evaluate whether osseous correction during surgery is able to correct glenohumeral joint
kinematics. The second objective is to compare OA patient's glenohumeral contact areas before
and after surgery with healthy subjects. The third objective is to identifying variations in
glenohumeral contact patterns after surgery with respect to the pre-and postoperative state
of the patients. The last objective is to evaluate the influence of the location of the
glenohumeral contact area after surgery on the long-term outcome and survival of the glenoid
component.
