Back to resultsClinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
Primary Purpose
Hip Joint, Arthritis, Degenerative
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
seleXys PC
RM
Sponsored by
About this trial
This is an interventional treatment trial for Hip Joint focused on measuring total hip replacement, roentgen stereophotogrammetric analysis
Eligibility 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
Sites / Locations
- Klinik für Orthopädie und Traumatologie, University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
seleXys PC
RM
Arm Description
seleXys PC cup combined with the optimys stem
RM Pressfit vitamys cup combined with the optimys stem
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03260465
First Posted
August 22, 2017
Last Updated
April 11, 2022
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03260465
Brief Title
Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
Official Title
A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Joint, Arthritis, Degenerative
Keywords
total hip replacement, roentgen stereophotogrammetric analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomised single-center study with 2 treatment arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
seleXys PC
Arm Type
Experimental
Arm Description
seleXys PC cup combined with the optimys stem
Arm Title
RM
Arm Type
Active Comparator
Arm Description
RM Pressfit vitamys cup combined with the optimys stem
Intervention Type
Device
Intervention Name(s)
seleXys PC
Intervention Description
Total hip arthroplasty using the seleXys PC cup
Intervention Type
Device
Intervention Name(s)
RM
Intervention Description
Total hip arthroplasty using the RM cup
Primary Outcome Measure Information:
Title
Wear Rate
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl Stoffel, Prof. Dr. med.
Phone
+41 61 315 27 51
Email
Karl.Stoffel@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ilona Ahlborn
Phone
+41 61 328 71 97
Email
ilona.ahlborn@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Stoffel, Prof. Dr. med.
Organizational Affiliation
Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Orthopädie und Traumatologie, University Hospital Basel
City
Basel
State/Province
BL
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Stoffel, Prof. Dr. med.
Phone
+41 (0) 61 9253841
Email
Karl.Stoffel@usb.ch
First Name & Middle Initial & Last Name & Degree
Ilona Ahlborn
Phone
+41 61 328 71 97
Email
ilona.ahlborn@usb.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
We'll reach out to this number within 24 hrs