Primary OsteoarthritisNCT05926622
Clinical and Radiological Outcomes of Medacta Shoulder System FR
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 1 site in France.
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
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2022to Mar 2037
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Générale Annecy
Annecy, 74000
Bruno Toussaint, Dr, 04 50 33 09 50, bruno.toussaint10@wanadoo.fr
About this study
Official title: Clinical and Radiological Outcomes of Medacta Shoulder System
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
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Osteonecrosis, Fractures, Bone
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 evaluating Constant & Murley Score
Constant \& Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively
Measured: 1, 2, 5 and 10 years
Functional outcome evaluating Oxford Shoulder Score
Oxford Shoulder Score (OSS): The Oxford Shoulder Score is a unidimensional score comprising 12 questions. Starting with 1 (best/fewest symptoms) to 5 (worst/most severe) which is awarded to correspond to the patient's symptoms. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.
Measured: 1, 2, 5 and 10 years
Radiographic performance of the implants evaluating presence of radiolucencies
presence of radiolucencies
Measured: 3 months, 1, 2, 5 and 10 years
Patient evaluation quality of life
EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Typically it is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions)
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 posted3 Jul 2023
- Study start15 Mar 2022
- Primary completionMar 2032 (estimated)
- Study completionMar 2037 (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
- Bruno Toussaint, Principal investigator, Clinique Générale Annecy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926622
- Sponsor's protocol ID
- P06.001.03
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2023
- 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
- NCT05926622
- Acronym / sponsor ID
- P06.001.03
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2037 (estimated)
- First posted
- 3 Jul 2023 (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.
Primary outcome
Survival Rate
Time frame: 10 years
Kaplan Meier method
5 secondary outcomes
Clinical outcome evaluating Constant & Murley Score
Time frame: 1, 2, 5 and 10 years
Functional outcome evaluating Oxford Shoulder Score
Time frame: 1, 2, 5 and 10 years
Radiographic performance of the implants evaluating presence of radiolucencies
Time frame: 3 months, 1, 2, 5 and 10 years
Patient evaluation 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.
Bruno Toussaint principal investigator
Clinique Générale Annecy
1 site in 1 country: 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 1 site in France.
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: looking for participants now, 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 1 site in France. 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?
Contact Arianna Girardi (+41 91 696 60 60, girardi@medacta.ch), or a site near the patient. 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.