Arthroplasty, Replacement, Hip
Conditions
Keywords
primary osteoarthritis, secondary osteoarthritis, femoral head fracture, necrosis
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 safety and performance.
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 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.
Interventions
DEVICEaneXys
150 patients with the aneXys cup
Sponsors
Mathys Ltd Bettlach
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cup migration after 2 years | 2 years | The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 10 years | The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score. |
| Visual analogue scale vor pain | 10 years | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain. |
| Visual analogue scale for satisfaction | 10 years | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction. |
| The Western Ontario and McMaster Universities Osteoarthritis Index | 10 years | The secondary endpoint will be the determination of the clinical outcome using the WOMAC. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAndreas Roth, Prof.
Universitätsklinik Leipzig
Outcome results
None listed