Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03382665|
Recruitment Status : Terminated (CE mark will not be renewed, PMCF data no longer required)
First Posted : December 26, 2017
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
|Condition or disease|
|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|
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.
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||March 2018|
- Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. [ Time Frame: baseline/Pre-op and 2 years (+/- 2 months) ]
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.
- Implant Survival Measured by the Number of Revisions. [ Time Frame: 2 years (+/- 2 month) ]Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.
- WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value [ Time Frame: baseline/Pre-op and 2 years (+/- 2 months) ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382665
|Helios Klinik Hildesheim|
|Hildesheim, Germany, 31135|
|Klinikum Osnabrück GmbH|
|Osnabrück, Germany, 49076|
|Asklepios Orthopädische Klinik Lindenlohe|
|Schwandorf In Bayern, Germany, 92421|
|Study Director:||Paola Vivoda||Zimmer Biomet|