M16.7 M16.1
Conditions
Interventions
Group 1: single-arm study. there is no comparison group
Prospective observational multicenter case series providing mid- to long-term post-market clinical data on the safety and performance of the an
Sponsors
Mathys Orthopädie GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study: - 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: The presence of any one of the following exclusion criteria will lead to exclusion of the participant: - 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 |
|---|---|
| The primary endpoint will be the occurrence of noise 2 years after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the determination of the clinical outcome using the HHS (Harris Hip Score), the VAS for pain and satisfaction. | — |
Countries
Germany
Contacts
Public ContactNatividad Zeleny
Mathys Orthopädie Gmbh
Outcome results
None listed