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

Rekrutierend

NCT-Nummer:
NCT03260465

Studienbeginn:
Oktober 2017

Letztes Update:
16.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Osteoarthritis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

Karl Stoffel, Prof. Dr. med.
Principal Investigator
Klinik für Orthopädie und Traumatologie, Universitätsspital Basel

Kontakt

Karl Stoffel, Prof. Dr. med.
Kontakt:
Phone: +41 61 315 27 51
E-Mail: Karl.Stoffel@usb.ch» Kontaktdaten anzeigen

Ilona Ahlborn
Kontakt:
Phone: +41 61 328 71 97
E-Mail: ilona.ahlborn@usb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinik für Orthopädie und Traumatologie, University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Karl Stoffel, Prof. Dr. med.
Phone: +41 (0) 61 9253841
E-Mail: Karl.Stoffel@usb.ch

Ilona Ahlborn
Phone: +41 61 328 71 97
E-Mail: ilona.ahlborn@usb.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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.

Studien-Arme

Experimental: seleXys PC
seleXys PC cup combined with the optimys stem
Active Comparator: RM
RM Pressfit vitamys cup combined with the optimys stem

Geprüfte Regime

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

Quelle: ClinicalTrials.gov