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

NCT03260465 | Active Not Recruiting

• 1 other identifier: 2017-00832; mu21Stoffel
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Joint; Arthritis, Degenerative

Keywords

total hip replacement; roentgen stereophotogrammetric analysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

seleXys PC

EXPERIMENTAL

seleXys PC cup combined with the optimys stem

Device: seleXys PC

RM

ACTIVE COMPARATOR

RM Pressfit vitamys cup combined with the optimys stem

Device: RM

Interventions

seleXys PC DEVICE

Total hip arthroplasty using the seleXys PC cup

seleXys PC

RM DEVICE

Total hip arthroplasty using the RM cup

RM

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Klinik für Orthopädie und Traumatologie, University Hospital Basel

Basel, Basel-Landschaft, 4031, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Karl Stoffel, Prof. Dr. med.

  Klinik für Orthopädie und Traumatologie, Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: October 30, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)