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

Launched by ZIMMER BIOMET · Dec 19, 2017

Keywords

ClinConnect Summary

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. ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient age at least 18 years
• • Fully conscious and capable patients
• • Signed informed consent
• • Stationary treatment
• • Merle d'Aubigné \< 12 Points, WOMAC Score \> 25 Points
• * Patients with at least one of the following indications:
• Indications for primary hip replacement:
• • Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis)
• • Rheumatoid arthritis
• • Functional deformities
• • Provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies)
• • Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques
• Revision THA:
• • Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis)
• • Bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors
• Exclusion Criteria:
• • Infections
• • Patients under 18 years
• • Pregnant or breastfeeding patients
• • Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse
• • Legal incapacity or restricted capacity
• • Participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months
• • Patients who are unable to attend to follow-up