Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
NCT ID: NCT04322916
Last Updated: 2020-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
675 participants
OBSERVATIONAL
2009-09-15
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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RM Pressfit vitamys
Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem
RM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup
Interventions
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RM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup
Eligibility Criteria
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Inclusion Criteria
* Primary implantation
* Age at inclusion: Between 18 and 95 years old
* Willing to participate in the follow-up
Exclusion Criteria
* 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
18 Years
95 Years
ALL
No
Sponsors
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Mathys Ltd Bettlach
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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20081020_Protocol_E_vitamys_V1
Identifier Type: -
Identifier Source: org_study_id
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