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

Mathys

Status: Unknown

Conditions: Arthropathy of Hip; Hip Replacement

Treatments: Device: RM Pressfit vitamys

Study type: Observational

Funder types: Industry

Identifiers

NCT04322916

20081020_Protocol_E_vitamys_V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 675 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

675 participants in 1 patient group

RM Pressfit vitamys

Description:

Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem

Treatment:

Device: RM Pressfit vitamys