Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03260465 |
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : February 4, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hip Joint Arthritis, Degenerative | Device: seleXys PC Device: RM | Not Applicable |
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 |

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 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Principal Investigator: | Karl Stoffel, Prof. Dr. med. | Klinik für Orthopädie und Traumatologie, Universitätsspital Basel |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
total hip replacement roentgen stereophotogrammetric analysis |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |