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

March 26, 2020 updated by: Mathys Ltd Bettlach
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

according to Eligibility Criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic evaluation
Time Frame: 6-12 weeks - 10 years
The second endpoint of interest is the occurence of osteolysis around the cup
6-12 weeks - 10 years
Adverse Events
Time Frame: 6-12 weeks - 10 years
Reporting of Adverse Events
6-12 weeks - 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mathys Ltd Bettlach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2009

Primary Completion (Actual)

March 28, 2012

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20081020_Protocol_E_vitamys_V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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