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

  • STATUS
    Recruiting
  • End date
    Feb 24, 2032
  • participants needed
    150
  • sponsor
    Mathys Ltd Bettlach
Updated on 24 January 2021
osteoarthritis

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.

Description

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.

Details
Condition Total hip replacement, Hip Replacement
Treatment aneXys
Clinical Study IdentifierNCT03274830
SponsorMathys Ltd Bettlach
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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