Status:
ACTIVE_NOT_RECRUITING
A Post Market Clinical Follow-up Study With the aneXys Cup
Lead Sponsor:
Mathys Ltd Bettlach
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18-75 years
Brief 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...
Detailed 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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2034
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03274830
Start Date
March 5 2020
End Date
September 1 2034
Last Update
October 3 2023
Active Locations (3)
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1
DRK Kliniken Berlin | Köpernick
Berlin, Germany
2
DRK Kliniken Berlin | Westend
Berlin, Germany
3
Universitätsklinikum Leipzig
Leipzig, Germany, 04107