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

Rheumatoid Arthritis Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Avascular Necrosis
• Bridging of Large Bone Defects
• Femoral Fractures
• Femur Fracture
• Fracture, Proximal Humeral
• Fractures, Bone
• Functional Deformities
• Hip Fractures
• Necrosis
• Osteoarthritis
• Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies)
• Pseudarthrosis
• Pseudoarthrosis
• Revision of Endoprosthesis-treated Hips
• Revisions
• Rheumatoid Arthritis
• Shoulder Fractures
• Trochanteric Fractures

• NCT number: NCT03382665
• Study type: Observational
• Source: Zimmer Biomet
• Status: Terminated
• Start date: January 2010
• Completion date: March 2018