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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Joint, Arthritis, Degenerative

Intervention / Treatment
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* Device: seleXys PC
* Device: RM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomised single-center study with 2 treatment arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: seleXys PC<br>seleXys PC cup combined with the optimys stem | Device: seleXys PC<br>* Total hip arthroplasty using the seleXys PC cup<br>|
| Active Comparator: RM<br>RM Pressfit vitamys cup combined with the optimys stem | Device: RM<br>* Total hip arthroplasty using the RM cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip replacement, roentgen stereophotogrammetric analysis