Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup

Arthritis, Degenerative Clinical Trial

Official title:

A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260465
• Other study ID #: 2017-00832; mu21Stoffel
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Karl Stoffel, Prof. Dr. med.
• Phone: +41 61 315 27 51
• Email: Karl.Stoffel[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
• Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
• Patients between the ages of 50 and 75 inclusive
• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

• Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
• Patients that offer no guarantee for regular follow-up controls
• Patients that have a revision surgery
• Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
• Patients that had a previous osteotomy of the femur or pelvis
• Pregnant women or those seeking to become pregnant
• Patients with a history of active infection

Related Conditions & MeSH terms

• Arthritis, Degenerative
• Hip Joint
• Osteoarthritis

Intervention

Device:
• seleXys PC
Total hip arthroplasty using the seleXys PC cup
• RM
Total hip arthroplasty using the RM cup

Locations

Country	Name	City	State
Switzerland	Klinik für Orthopädie und Traumatologie, University Hospital Basel	Basel	BL

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wear Rate	The principal purpose of this study is to compare the modular seleXys PC Cup with a vitamys inlay to the monoblock RM Pressfit vitamys cup by means of wear rate. In addition, the migration of the two cups and the optimys stem, respectively, will be evaluated.	3 years