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