A Post Market Clinical Follow-up Study With the aneXys Cup (NCT03274830) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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