Trials / Terminated

TerminatedNCT03382665

Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction

Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction

Status: Terminated
Phase: —
Study type: Observational
Enrollment: 70 (actual)

Sponsor: Zimmer Biomet · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and revision total hip arthroplasty.

Detailed description

This multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the Hyperion® system. The performance of the Hyperion® THA System will be evaluated using standard scoring systems (Merle d'Aubigné Score, HOOS Score). Safety will be evaluated by adverse event reporting. The study will be performed at 6 sites, enrolling in total 70 patients. Follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. The scores will be filled in pre-operatively and post-operatively until 5 years. In order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. Xrays will be done pre-operatively, immediate post-operatively and at each of the Follow-up visits.

Conditions

Timeline

Start date: 2010-01-01
Primary completion: 2017-08-01
Completion: 2018-03-01
First posted: 2017-12-26
Last updated: 2023-04-07
Results posted: 2020-08-21

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT03382665. Inclusion in this directory is not an endorsement.