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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. | Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of >4 points compared to the pre-operative score points. The patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome. | baseline/Pre-op and 2 years (+/- 2 months) | 
| Implant Survival Measured by the Number of Revisions. | Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method. | 2 years (+/- 2 month) | 
| WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value | at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values Scale: min 0-Max 100; Higher values mean worse outcome | baseline/Pre-op and 2 years (+/- 2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision total hip arthroplasty, Medical Device, Post Market Surveillance Study, Primary total hip arthroplasty