Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
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|ClinicalTrials.gov Identifier: NCT03382665|
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
|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, Harris Hip Score, HOOS Score) and using documentation of sintering, wound healing and radiographic/clinical signs of loosening. 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|
|Estimated Study Completion Date :||December 2026|
- Pain and walking ability determined by a Merle d' Aubigné Score increase of >4 points. [ Time Frame: 2 years (+/- 2 month) ]Pain and walking ability determined by a Merle d' Aubigné Score increase of >4 points compared to the pre-operative score points determined by the inclusion criteria of a Merle d' Aubigné < 12 points.
- 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.
- Patient satisfaction measured by the WOMAC Scores and decrease in min. 25 points. [ Time Frame: 2 years (+/- 2 month) ]Patient satisfaction measured by the WOMAC Scores and decrease in min. 25 points compared to the pre-operative determined points (WOMAC Score > 25 points pre-operative)
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, Germany, 92421|
|Study Director:||Paola Vivoda||Zimmer Biomet|