Arthropathy of Hip, Hip Replacement
Conditions
Keywords
Primary osteoarthritis, Secondary osteoarthritis, Inflammatory arthritis, Congenital dysplasia, Femoral head fracture
Brief summary
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Detailed description
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study. The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.
Interventions
DEVICERM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup
Sponsors
Mathys Ltd Bettlach
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent form (signed by participant and investigator) * Primary implantation * Age at inclusion: Between 18 and 95 years old * Willing to participate in the follow-up
Exclusion criteria
* Missing Informed consent form * Known or suspected non-compliance (e.g. drug or alcohol abuse) * Enrollment of the investigator, his/her family, employees and other dependent persons * Patient younger than 18 years old * Revision surgery * Presence of sepsis or malignant tumors * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (modified after Haddad et al, 1990) | 2 years | The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation | 6-12 weeks - 10 years | The second endpoint of interest is the occurence of osteolysis around the cup |
| Adverse Events | 6-12 weeks - 10 years | Reporting of Adverse Events |
Outcome results
None listed