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

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ClinicalTrials.gov Identifier: NCT03260465
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hip Joint Arthritis, Degenerative Device: seleXys PC Device: RM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomised single-center study with 2 treatment arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: seleXys PC
seleXys PC cup combined with the optimys stem
 Device: seleXys PC
Total hip arthroplasty using the seleXys PC cup
Active Comparator: RM
RM Pressfit vitamys cup combined with the optimys stem
 Device: RM
Total hip arthroplasty using the RM cup


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260465


Contacts
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Contact: Karl Stoffel, Prof. Dr. med. +41 61 315 27 51 Karl.Stoffel@usb.ch
Contact: Ilona Ahlborn +41 61 328 71 97 ilona.ahlborn@usb.ch

Locations
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Switzerland
Klinik für Orthopädie und Traumatologie, University Hospital Basel Recruiting
Basel, BL, Switzerland, 4031
Contact: Karl Stoffel, Prof. Dr. med.    +41 (0) 61 9253841    Karl.Stoffel@usb.ch   
Contact: Ilona Ahlborn    +41 61 328 71 97    ilona.ahlborn@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Karl Stoffel, Prof. Dr. med. Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03260465    
Other Study ID Numbers: 2017-00832; mu21Stoffel
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
total hip replacement
roentgen stereophotogrammetric analysis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases