Hip JointNCT03260465
Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
A study testing seleXys PC and RM in people with Hip Joint and Arthritis, Degenerative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hip Joint, Arthritis, Degenerative
- What is being tested?
- seleXys PC and RM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Oct 2017to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Orthopädie und Traumatologie, University Hospital Basel
Basel, Basel-Landschaft, 4031
About this study
Official title: A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
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
- Being tested
- seleXys PC, RM
- Keywords
- total hip replacement, roentgen stereophotogrammetric analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seleXys PCDevice
Total hip arthroplasty using the seleXys PC cup
RMDevice
Total hip arthroplasty using the RM cup
| Study group | Role | What they receive |
|---|---|---|
| seleXys PC | Experimental | seleXys PC cup combined with the optimys stem Receives: Device: seleXys PC |
| RM | Active comparator | RM Pressfit vitamys cup combined with the optimys stem Receives: Device: RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start30 Oct 2017
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip JointStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomised single-center study with 2 treatment arms.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Stoffel, Prof. Dr. med., Principal investigator, Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260465
- Sponsor's protocol ID
- 2017-00832; mu21Stoffel
- Other IDs
- 2017
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2017
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
- ClinicalTrials.gov ID
- NCT03260465
- Acronym / sponsor ID
- 2017-00832; mu21Stoffel
- Conditions
- Hip Joint, Arthritis, Degenerative
- Keywords
- total hip replacement, roentgen stereophotogrammetric analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomised single-center study with 2 treatment arms.
| Arm | Type | Receives |
|---|---|---|
| seleXys PC | Experimental | Device: seleXys PCseleXys PC cup combined with the optimys stem |
| RM | Active comparator | Device: RMRM Pressfit vitamys cup combined with the optimys stem |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seleXys PCTotal hip arthroplasty using the seleXys PC cup | Device | seleXys PC |
| RMTotal hip arthroplasty using the RM cup | Device | RM |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Stoffel, Prof. Dr. med. principal investigator
Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seleXys PC and RM in people with Hip Joint and Arthritis, Degenerative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.