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NCT Number: NCT03260465

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Joint Arthritis Arthritis, Degenerative Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Orthopädie und Traumatologie, University Hospital Basel

Basel, Basel-Landschaft, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

seleXys PC

Device

Total hip arthroplasty using the seleXys PC cup

RM

Device

Total hip arthroplasty using the RM cup

Primary outcomes

  1. Wear Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2017
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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