Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction (NCT03382665) | Clinical Trial Compass
TerminatedNot Applicable
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Stopped: CE mark will not be renewed, PMCF data no longer required
Germany70 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
Timeframe: baseline/Pre-op and 2 years (+/- 2 months)
2
Implant Survival Measured by the Number of Revisions.
Timeframe: 2 years (+/- 2 month)
3
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value
Timeframe: baseline/Pre-op and 2 years (+/- 2 months)