Active — Not RecruitingNot Applicable

A Post Market Clinical Follow-up Study With the aneXys Cup

Germany102 participantsStarted 2020-03-05

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 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: * Informed consent form (signed by participant and investigator) * Primary implantation * Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible. * Age at inclusion: between 18 and 75 years old * Willing to participate in the follow-up examinations * Complete recovery is expected Exclusion Criteria: * Missing informed consent form (signed by participant and investigator) * Known or suspected non-compliance (e.g. drug or alcohol abuse) * Enrolment of the investigator, his/her family, employees and other dependent persons * Patients younger 18 years old * Revision surgery * Presence of sepsis or malignant tumours * ASA (American Society of Anesthesiologists) Classification \>3 * Pregnancy

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

Cup migration after 2 years

Timeframe: 2 years

Trial details

NCT IDNCT03274830

SponsorMathys Ltd Bettlach

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-03-18

View on ClinicalTrials.gov More Arthroplasty, Replacement, Hip trials

Who can participate

Age range

18 Years – 75 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.