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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RM Pressfit vitamys | Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RM Pressfit vitamys | Device | Implantation of a RM Pressfit vitamys hip cup |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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according to Eligibility Criteria
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485345 | Derived | Afghanyar Y, Joser S, Tecle J, Drees P, Dargel J, Rehbein P, Kutzner KP. The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up. BMC Musculoskelet Disord. 2021 Jan 23;22(1):107. doi: 10.1186/s12891-021-03981-8. |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6-12 weeks - 10 years |