M16.1 M16.7
Conditions
Interventions
Group 1: single-arm study (no comparison group)
Patients who have been treatet with an aneXys hip cup and a ceramys inlay are re-examined 4 times after surgery using the following scores:
-MONA Que
Sponsors
Mathys AG Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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 mentioned above - Complete recovery is expected
Exclusion criteria
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 - Patients not able to speak and understand the national language of the study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as assessment of acoustic emission based on the MONA Questionnaire. For assessment of the primary endpoint, the MONA Questionnaire is assessed at 24 months (range: 24-26 months) postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the determination of the clinical outcome using the HHS (Harris Hip Score), UCLA (University of California) Activity Score, EQ-5D-5L Score, FJS (Forgotten-Joint-Score) and VAS pain and satisfaction. | — |
Countries
Germany
Contacts
Public ContactChiara Lenarduzzi
Mathys AG Bettlach
Outcome results
None listed