Arthroplasty, Replacement, HipNCT03274830
A Post Market Clinical Follow-up Study With the aneXys Cup
An observational study of Arthroplasty, Replacement, Hip, run by Mathys Ltd Bettlach at 3 sites in Germany.
Trial summary
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys 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 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- aneXys
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 3 sitesGermany
- Study dates
- 5 Mar 2020to Mar 2032
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: see eligibility criteria
Who may be able to join
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
- Age at inclusion: between 18 and 75 years old
- Willing to participate in the follow-up examinations
- Complete recovery is expected
Who cannot join
- Missing informed consent form (signed by participant and investigator)
- Known or suspected non-compliance (e.g. drug or alcohol abuse)
- Enrolment of the investigator, his/her family, employees and other dependent persons
- Patients younger 18 years old
- Revision surgery
- Presence of sepsis or malignant tumours
- ASA (American Society of Anesthesiologists) Classification >3
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
DRK Kliniken Berlin | Köpernick
Berlin
DRK Kliniken Berlin | Westend
Berlin
Universitätsklinikum Leipzig
Leipzig, 04107
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 aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Read the detailed description
Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.
Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- aneXys
- Keywords
- primary osteoarthritis, secondary osteoarthritis, femoral head fracture, necrosis
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aneXysDevice
150 patients with the aneXys cup
| Study group | Role | What they receive |
|---|---|---|
| aneXys | cases with aneXys cup and Mathys hip stem Receives: Device: aneXys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup migration after 2 years
The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
Measured: 2 years
Secondary outcomes (4)
Harris Hip Score
The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.
Measured: 10 years
Visual analogue scale vor pain
The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.
Measured: 10 years
Visual analogue scale for satisfaction
The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.
Measured: 10 years
The Western Ontario and McMaster Universities Osteoarthritis Index
The secondary endpoint will be the determination of the clinical outcome using the WOMAC.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start5 Mar 2020
- Primary completion18 Mar 2024
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathys Ltd Bettlach
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Roth, Prof., Principal investigator, Universitätsklinik Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274830
- Sponsor's protocol ID
- 1602_V03_10042019
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2017
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Follow-up Study With the aneXys Cup
- ClinicalTrials.gov ID
- NCT03274830
- Acronym / sponsor ID
- 1602_V03_10042019
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- primary osteoarthritis, secondary osteoarthritis, femoral head fracture, necrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mathys Ltd BettlachIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- Mar 2032 (estimated)
- First posted
- 7 Sep 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.
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Detailed description
Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.
Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aneXys | – | Device: aneXyscases with aneXys cup and Mathys hip stem |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- see eligibility criteria
Key inclusion criteria (6 listed)
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
- Age at inclusion: between 18 and 75 years old
- Willing to participate in the follow-up examinations
Key exclusion criteria (8 listed)
- Missing informed consent form (signed by participant and investigator)
- Known or suspected non-compliance (e.g. drug or alcohol abuse)
- Enrolment of the investigator, his/her family, employees and other dependent persons
- Patients younger 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 |
|---|---|---|
| aneXys150 patients with the aneXys cup | Device | aneXys |
Primary outcome
Cup migration after 2 years
Time frame: 2 years
The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
4 secondary outcomes
Harris Hip Score
Time frame: 10 years
Visual analogue scale vor pain
Time frame: 10 years
Visual analogue scale for satisfaction
Time frame: 10 years
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 10 years
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 6 Feb 2026.
- 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.
Andreas Roth, Prof. principal investigator
Universitätsklinik Leipzig
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip, run by Mathys Ltd Bettlach at 3 sites in Germany.
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 6 inclusion and 8 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Cup migration after 2 years (time frame: 2 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 6 Feb 2026.