NCT04962854

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

July 10, 2021

Last Update Submit

July 10, 2021

Conditions

Bone Mineral Density

Keywords

Total Hip ArthroplastyDEXA

Outcome Measures

Primary Outcomes (1)

  • Dexa meassurments

    Changes in BMD according to DeLee and Charnley Zones

    24 Months

Study Arms (2)

Monoblock Cup

53 patients received a monoblock cup (RM Pressfit vitamys®)

Modular Cup

64 patients received a modular cup (ANA.NOVA® Implantec)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who either received a monoblock cup (RM Pressfit vitamys®; Mathys Ltd. Bettlach, Switzerland), or a titanium shell (ANA.NOVA® Implantec, Mödling, Austria) between January 2016 and May 2017. 117 patients (female 69, male 48), mean age was 68 years (range, 43 to 89 years)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 15, 2021

Study Start

January 1, 2016

Primary Completion

May 9, 2019

Study Completion

April 1, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share