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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2018-03-31

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.

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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.

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No