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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03260465

Enrollment

Registered

2017-08-24

Start date

2017-10-30

Completion date

2025-08-31

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Degenerative, Hip Joint

Keywords

total hip replacement, roentgen stereophotogrammetric analysis

Brief 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.

Interventions

DEVICEseleXys PC

Total hip arthroplasty using the seleXys PC cup

DEVICERM

Total hip arthroplasty using the RM cup

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective, randomised single-center study with 2 treatment arms.

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Wear Rate	3 years	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026