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

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 100 patients in 3 clinics will be included. In each clinic 10-57 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