Status:
TERMINATED
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief 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...
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 per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03382665
Start Date
January 1 2010
End Date
March 1 2018
Last Update
April 7 2023
Active Locations (3)
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1
Helios Klinik Hildesheim
Hildesheim, Germany, 31135
2
Klinikum Osnabrück GmbH
Osnabrück, Germany, 49076
3
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf in Bayern, Germany, 92421