Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

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 RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Detailed Description
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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.

Official Title
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Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

Conditions
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Arthropathy of Hip, Hip Replacement

Intervention / Treatment
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* Device: RM Pressfit vitamys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| RM Pressfit vitamys<br>Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem | Device: RM Pressfit vitamys<br>* Implantation of a RM Pressfit vitamys hip cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (modified after Haddad et al, 1990) | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation | The second endpoint of interest is the occurence of osteolysis around the cup | 6-12 weeks - 10 years | 
| Adverse Events | Reporting of Adverse Events | 6-12 weeks - 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, Inflammatory arthritis, Congenital dysplasia, Femoral head fracture