Arthropathy of HipNCT04322916
Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
An observational study of Arthropathy of Hip and Hip Replacement, run by Mathys Ltd Bettlach.
Trial summary
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arthropathy of Hip, Hip Replacement
- What is being tested?
- RM Pressfit vitamys
- Type of treatment
- Medical device
- How many people
- 675 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2009to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: according to Eligibility Criteria
Who may be able to join
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Age at inclusion: Between 18 and 95 years old
- Willing to participate in the follow-up
Who cannot join
- Missing Informed consent form
- Known or suspected non-compliance (e.g. drug or alcohol abuse)
- Enrollment of the investigator, his/her family, employees and other dependent persons
- Patient younger than 18 years old
- Revision surgery
- Presence of sepsis or malignant tumors
- Pregnancy
About this study
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Read the detailed description
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.
The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.
- Conditions
- Arthropathy of Hip, Hip Replacement
- Being tested
- RM Pressfit vitamys
- Keywords
- Primary osteoarthritis, Secondary osteoarthritis, Inflammatory arthritis, Congenital dysplasia, Femoral head fracture
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RM Pressfit vitamysDevice
Implantation of a RM Pressfit vitamys hip cup
| Study group | Role | What they receive |
|---|---|---|
| RM Pressfit vitamys | Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem Receives: Device: RM Pressfit vitamys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (modified after Haddad et al, 1990)
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 2 years
Secondary outcomes (2)
Radiographic evaluation
The second endpoint of interest is the occurence of osteolysis around the cup
Measured: 6-12 weeks - 10 years
Adverse Events
Reporting of Adverse Events
Measured: 6-12 weeks - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start15 Sep 2009
- Primary completion28 Mar 2012
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathys Ltd Bettlach
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322916
- Sponsor's protocol ID
- 20081020_Protocol_E_vitamys_V1
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afghanyar Y, Joser S, Tecle J, Drees P, Dargel J, Rehbein P, Kutzner KP. The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up. BMC Musculoskelet Disord. 2021 Jan 23;22(1):107. doi: 10.1186/s12891-021-03981-8.
PubMed 33485345
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
- ClinicalTrials.gov ID
- NCT04322916
- Acronym / sponsor ID
- 20081020_Protocol_E_vitamys_V1
- Conditions
- Arthropathy of Hip, Hip Replacement
- Keywords
- Primary osteoarthritis, Secondary osteoarthritis, Inflammatory arthritis, Congenital dysplasia, Femoral head fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Mathys Ltd BettlachIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2009 (actual)
- Primary completion
- 28 Mar 2012 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 26 Mar 2020 (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.
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Detailed description
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.
The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RM Pressfit vitamys | – | Device: RM Pressfit vitamysParticipants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- according to Eligibility Criteria
Key inclusion criteria (4 listed)
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Age at inclusion: Between 18 and 95 years old
- Willing to participate in the follow-up
Key exclusion criteria (7 listed)
- Missing Informed consent form
- Known or suspected non-compliance (e.g. drug or alcohol abuse)
- Enrollment of the investigator, his/her family, employees and other dependent persons
- Patient younger than 18 years old
- Revision surgery
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 |
|---|---|---|
| RM Pressfit vitamysImplantation of a RM Pressfit vitamys hip cup | Device | RM Pressfit vitamys |
Primary outcome
Harris Hip Score (modified after Haddad et al, 1990)
Time frame: 2 years
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
2 secondary outcomes
Radiographic evaluation
Time frame: 6-12 weeks - 10 years
Adverse Events
Time frame: 6-12 weeks - 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 33485345Afghanyar Y, Joser S, Tecle J, Drees P, Dargel J, Rehbein P, Kutzner KP. The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up. BMC Musculoskelet Disord. 2021 Jan 23;22(1):107. doi: 10.1186/s12891-021-03981-8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Hip and Hip Replacement, run by Mathys Ltd Bettlach.
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: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Harris Hip Score (modified after Haddad et al, 1990) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322916, which also lists 1 linked publication.
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 30 Mar 2020.