A Post Market Clinical Follow-up Study With the aneXys Cup
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|ClinicalTrials.gov Identifier: NCT03274830|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment|
|Arthroplasty, Replacement, Hip||Device: aneXys|
Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 150 patients in 3 clinics will be included. In each clinic 50 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.
Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||A Post Market Clinical Follow-up Study With the aneXys Cup|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||April 2030|
cases with aneXys cup and Mathys hip stem
150 patients with the aneXys cup
- Cup migration after 2 years [ Time Frame: 2 years ]The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
- Harris Hip Score [ Time Frame: 10 years ]The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.
- Visual analogue scale vor pain [ Time Frame: 10 years ]The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.
- Visual analogue scale for satisfaction [ Time Frame: 10 years ]The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.
- The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 10 years ]The secondary endpoint will be the determination of the clinical outcome using the WOMAC.
- Osteolysis [ Time Frame: 6-12 weeks - 10 years ]The first endpoint of interest is the occurrence of osteolysis around the cup.
- Lucent lines [ Time Frame: 6-12 weeks - 10 years ]The second endpoint of interest is the occurrence of lucent lines around the cup.
- Complications [ Time Frame: post-op - 10 years ]The first safety endpoint will be the number of complications with respect to the investigational product.
- Revisions [ Time Frame: post-op - 10 years ]The second safety endpoint will be the number revisions with respect to the investigational product.
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): NCT03274830
|Contact: Sandra Rosser, MSc||+41 32 644 17 firstname.lastname@example.org|
|Contact: Peter Münger, MPH||+41 32 644 14 email@example.com|
|Marienstift Arnstadt||Not yet recruiting|
|Arnstadt, Germany, 99310|
|Contact: Karsten Heubach, Dr. med. +49 (36) 28 720 733 firstname.lastname@example.org|
|Currently Defined||Not yet recruiting|
|Leipzig, Germany, 04107|
|Principal Investigator:||Andreas Roth, Prof.||Universitätsklinik Leipzig|