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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04322916
Other study ID # 20081020_Protocol_E_vitamys_V1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 15, 2009
Est. completion date April 2022

Study information

Verified date March 2020
Source Mathys Ltd Bettlach
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 675
Est. completion date April 2022
Est. primary completion date March 28, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
RM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mathys Ltd Bettlach

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Radiographic evaluation The second endpoint of interest is the occurence of osteolysis around the cup 6-12 weeks - 10 years
Secondary Adverse Events Reporting of Adverse Events 6-12 weeks - 10 years
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