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

Arthropathy of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04322916
• Other study ID #: 20081020_Protocol_E_vitamys_V1
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Hip Replacement
• Joint Diseases

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