Primary OsteoarthritisNCT05002335
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 3 sites in Belgium.
Trial summary
This is a post-market surveillance study 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
- 3 sitesBelgium
- Study dates
- 6 Oct 2020to 31 Dec 2027
- 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 Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market 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)
Show all 10Show fewer
- 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
3 sites in 1 country.
Belgium3 sites
AZ Sint-Jan
Bruges, 8000
AZ Sint-Lucas
Bruges, 8310
Clinique St-Luc Bouge
Namur, 5004
About this study
This is a post-market surveillance study 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
Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Kaplan Meier method
Measured: 5 years
Secondary outcomes (5)
Clinical outcome; Constant and Murley score
Constant \& Murley Score: Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.
Measured: 1, 2, and 5 years
Functional outcome: Oxford Shoulder Score
Oxford Shoulder Score: It contains 12 items, each with 5 potential answers. A mark between 1 (best/fewest symptoms) and 5 (worst/most severe) is awarded to correspond to the patient's symptoms. The combined total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability
Measured: 1, 2, and 5 years
Radiographic performance of the implants: Presence of radiolucencies
Presence of radiolucencies
Measured: 3 months, 1, 2, and 5 years
Quality of life assesed by EQ-5D-5L score
EQ-5D-5L score: 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 1, 2, and 5 years
Number of Intraoperative and postoperative Adverse events
Intraoperative and postoperative adverse events
Measured: intraop, 3 months, 1, 2, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start6 Oct 2020
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Dec 2027 (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
- Bart Berghs, MD, Principal investigator, AZ Sint-Jan (Brugge, Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002335
- Sponsor's protocol ID
- P06.001.05
- Status last verified
- Jun 2025
- First submitted
- 4 Aug 2021
- 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 (BE)
- ClinicalTrials.gov ID
- NCT05002335
- Acronym / sponsor ID
- P06.001.05
- 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
- 6 Oct 2020 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2021 (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-market surveillance study 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 Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
Key inclusion criteria (10 listed)
- Patients older than 18 years
- Patient with one of the following diagnosis:
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 SystemPerformance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System | Device | – |
Primary outcome
Survival rate
Time frame: 5 years
Kaplan Meier method
5 secondary outcomes
Clinical outcome; Constant and Murley score
Time frame: 1, 2, and 5 years
Functional outcome: Oxford Shoulder Score
Time frame: 1, 2, and 5 years
Radiographic performance of the implants: Presence of radiolucencies
Time frame: 3 months, 1, 2, and 5 years
Quality of life assesed by EQ-5D-5L score
Time frame: 1, 2, and 5 years
Number of Intraoperative and postoperative Adverse events
Time frame: intraop, 3 months, 1, 2, and 5 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.
Bart Berghs, MD principal investigator
AZ Sint-Jan (Brugge, Belgium)
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 Primary Osteoarthritis and Secondary Osteoarthritis, run by Medacta International SA at 3 sites in Belgium.
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 10 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 3 sites in Belgium. 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: 5 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.