Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
1 other identifier
observational
675
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2012
CompletedFirst Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 30, 2020
March 1, 2020
2.5 years
March 24, 2020
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Radiographic evaluation
6-12 weeks - 10 years
Adverse Events
6-12 weeks - 10 years
Study Arms (1)
RM Pressfit vitamys
Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem
Interventions
Eligibility Criteria
according to Eligibility Criteria
You may qualify if:
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Willing to participate in the follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33485345DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 26, 2020
Study Start
September 15, 2009
Primary Completion
March 28, 2012
Study Completion
April 1, 2022
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share