Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04962854 |
| Other study ID # |
DEXA THA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
St. Vincent Hospital, Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study was performed as a prospective, single center study at the Department of
Orthopedics, Sacred Heart of Jesus Hospital Vienna, Austria. 117 patients were enrolled in a
from January 2016 to May 2017. 53 patients received an isoelastic monoblock cup (RM Pressfit
vitamys® Mathys) and 64 patients received a metal- backed modular cup (ANA.NOVA® ImplanTec).
Dual-energy x-ray absorptiometry scans according to DeLee and Charnley Zones were performed
at time points 0, 3, 6, 12, and 24 months after surgery. The aim of thise study was to
compare changes in BMD between an isoelastic monoblock cup and a titanium modular cup. We
hypothesized that the more elastic monoblock cup performs better than the more rigid modular
cup with regard to changes in BMD.
Description:
The study was performed as a prospective, single center study at the Department of
Orthopedics, Sacred Heart of Jesus Hospital Vienna, Austria.
Inclusion criteria were as follows: any patient aged from 18 years onwards undergoing primary
cementless THA for degenerative joint disease, including osteoarthritis, post-traumatic
arthritis, congenital hip dysplasia and avascular necrosis. Excluded were all patients with
malignant diseases and pregnant women, additionally, patients were excluded if severe
complications such as fracture or revision surgery occurred during the study period.
Patients were enrolled from January 2016 to May 2017, a total of 117 patients were included.
All patients underwent uncemented THA, patients either received a monoblock cup (RM Pressfit
vitamys®; Mathys Ltd. Bettlach, Switzerland), or a titanium shell (ANA.NOVA® Implantec,
Mödling, Austria). DEXA measurements according to the DeLee and Charnley Zones were performed
postoperatively, 3, 6, 12 and 24 months after primary hip arthroplasty. Bone mineral density
(BMD) was measured by using the bone densiometer (Lunar, Prodigy, GE Medical Sytsems). A
special legholder was used to fix the leg to ensure the same rotation and avoid measurement
errors. DEXA measurements were performed and analyzed by two trained authors. Statistical
analysis focused on differences in BMD between monoblock cup and modular cup after 3, 6, 12
and 24 months as well as changes in BMD in relation to cup inclination. In order to gain
valid results, the nonparametric Wilcoxon rank-sum test was used. We used t-Test to evaluate
differences to the baseline. A probability value of p ≤0.05 was considered as statistically
significant. Data was analyzed using Microsoft Excel® and SPSS® (version 26.0, SPSS Inc.,
Chicago, IL, USA) representing standard statistical software. We hypothesized that the more
elastic monoblock cup performs better than the more rigid modular cup with regard to changes
in BMD.
