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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: aneXys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aneXys<br>cases with aneXys cup and Mathys hip stem | Device: aneXys<br>* 150 patients with the aneXys cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cup migration after 2 years | The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score. | 10 years | 
| Visual analogue scale vor pain | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain. | 10 years | 
| Visual analogue scale for satisfaction | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction. | 10 years | 
| The Western Ontario and McMaster Universities Osteoarthritis Index | The secondary endpoint will be the determination of the clinical outcome using the WOMAC. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary osteoarthritis, secondary osteoarthritis, femoral head fracture, necrosis