Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
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|ClinicalTrials.gov Identifier: NCT04322916|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2020
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment|
|Arthropathy of Hip Hip Replacement||Device: RM Pressfit vitamys|
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.
|Study Type :||Observational|
|Actual Enrollment :||675 participants|
|Official Title:||Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem|
|Actual Study Start Date :||September 15, 2009|
|Actual Primary Completion Date :||March 28, 2012|
|Estimated Study Completion Date :||April 2022|
RM Pressfit vitamys
Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem
Device: RM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup
- Harris Hip Score (modified after Haddad et al, 1990) [ Time Frame: 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.
- Radiographic evaluation [ Time Frame: 6-12 weeks - 10 years ]The second endpoint of interest is the occurence of osteolysis around the cup
- Adverse Events [ Time Frame: 6-12 weeks - 10 years ]Reporting of Adverse Events