An observational study in Arthroplasty, Replacement, Hip, sponsored by Mathys Ltd Bettlach. Active, not recruiting at 3 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Mathys Ltd Bettlach · Observational
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
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 100 patients in 3 clinics will be included. In each clinic 10-57 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.
90 studies on the registry are indexed under Necrosis; 23 are open to participants now.
This study's enrollment of 102 is above the median of 78 across 33 observational studies indexed under Necrosis.
Browse Necrosis studies →Mathys Ltd Bettlach is the lead sponsor of 4 studies on the registry; none are open to participants now.
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see eligibility criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cases with aneXys cup and Mathys hip stem
Device: aneXys
150 patients with the aneXys cup
Cup migration after 2 years
The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
Time frame: 2 years
Harris Hip Score
The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.
Time frame: 10 years
Visual analogue scale vor pain
The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.
Time frame: 10 years
Visual analogue scale for satisfaction
The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.
Time frame: 10 years
The Western Ontario and McMaster Universities Osteoarthritis Index
The secondary endpoint will be the determination of the clinical outcome using the WOMAC.
Time frame: 10 years
Osteolysis
The first endpoint of interest is the occurrence of osteolysis around the cup.
Time frame: 6-12 weeks - 10 years
Lucent lines
The second endpoint of interest is the occurrence of lucent lines around the cup.
Time frame: 6-12 weeks - 10 years
Complications
The first safety endpoint will be the number of complications with respect to the investigational product.
Time frame: post-op - 10 years
Revisions
The second safety endpoint will be the number revisions with respect to the investigational product.
Time frame: post-op - 10 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Mathys Ltd Bettlach