Primary OsteoarthritisNCT03547947
Clinical and Radiological Outcomes of Medacta Shoulder System
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 6 sites in 3 countries.
Trial summary
This is a post-marketing surveillance on Medacta Shoulder System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy
- What is being tested?
- Medacta Shoulder System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 13 Jun 2018to Apr 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Who may be able to join
- Patients older than 18 years
- Patient with one of the following diagnosis:
- Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty
Who cannot join
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspect infections (at the time of surgery)
- Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Switzerland4 sites
Orthopädie Sonnenhof
Bern, Canton of Bern, 3006
Inselspital
Bern
Lindenhofspital
Bern
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,
Sankt Gallen
Germany1 site
Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
München
About this study
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Fracture
- Being tested
- Medacta Shoulder System
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Osteonecrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medacta Shoulder SystemDevice
Total Shoulder Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Kaplan Meier method
Measured: 10 years
Secondary outcomes (5)
Clinical outcome
Constant \& Murley Score
Measured: 1, 2, 5 and 10 years
Functional outcome
Oxford Shoulder Score
Measured: 1, 2, 5 and 10 years
Radiographic performance of the implants
presence of radiolucencies
Measured: 3 months, 1, 2, 5 and 10 years
Quality of life
EQ-5D
Measured: 1, 2, 5 and 10 years
Adverse events
record of adverse event
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start13 Jun 2018
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Zumstein, Prof Dr. Med, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547947
- Sponsor's protocol ID
- P06.001.01
- Status last verified
- Jun 2025
- First submitted
- 23 May 2018
- Last updated
- 29 Sep 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Medacta Shoulder System
- ClinicalTrials.gov ID
- NCT03547947
- Acronym / sponsor ID
- P06.001.01
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Fracture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 6 Jun 2018 (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 post-marketing surveillance on Medacta Shoulder System
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patient with one of the following diagnosis:
- Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty
Key exclusion criteria (4 listed)
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspect infections (at the time of surgery)
- Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of 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 |
|---|---|---|
| Medacta Shoulder SystemTotal Shoulder Arthroplasty | Device | – |
Primary outcome
Survival rate
Time frame: 10 years
Kaplan Meier method
5 secondary outcomes
Clinical outcome
Time frame: 1, 2, 5 and 10 years
Functional outcome
Time frame: 1, 2, 5 and 10 years
Radiographic performance of the implants
Time frame: 3 months, 1, 2, 5 and 10 years
Quality of life
Time frame: 1, 2, 5 and 10 years
Adverse events
Time frame: up to 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 29 Sep 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.
Matthias Zumstein, Prof Dr. Med principal investigator
Insel Gruppe AG, University Hospital Bern
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 6 sites in 3 countries.
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 3 inclusion and 4 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland, France, 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?
Survival rate (time frame: 10 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 29 Sep 2025.