Arthritis ShoulderNCT05062252
Mirror Medacta Shoulder System Pivotal Trial
A study testing Mirror Medacta Shoulder System and Medacta Shoulder System in people with Arthritis Shoulder and Post-traumatic Arthrosis of Other Joints, Upper Arm, run by Medacta International SA at 2 sites in Switzerland.
Trial summary
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Shoulder, Post-traumatic Arthrosis of Other Joints, Upper Arm
- What is being tested?
- Mirror Medacta Shoulder System and Medacta Shoulder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Jan 2022to 28 Feb 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 yr
- Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
- Willingness and ability to comply with study protocol
Who cannot join
- Medical condition or balance impairment that could lead to falls
- Prior rotator cuff surgery
- Cuff tear arthropathy/insufficient rotator cuff
- Insufficient bone quality which may affect the stability of the implant
- Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
- Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
Show all 18Show fewer
- Active metastatic or neoplastic disease at the shoulder joint
- Chemotherapy treatment/radiotherapy within 6 mo before surgery
- >5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
- Pregnancy or plan to become pregnant during study period
- Inability to understand study or a history of noncompliance with medical advice
- Alcohol or drug abuse
- Current enrollment in any clinical research study that might interfere with this study
- Metal allergies or sensitivity.
- Previous or current infection at or near the site of implantation.
- Current distant or systemic infection
- Patient, whose infomed consent form should be taken in an emergency situation
- ONLY for women of childbearing age: a positive pregnancy test (urine / blood)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Lindenhofgruppe AG - Orthopädie Sonnenhof
Bern, 3006
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
Sankt Gallen, 9007
About this study
Official title: Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
- Being tested
- Mirror Medacta Shoulder System, Medacta Shoulder System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Medacta Shoulder SystemDevice
Anatomic total shoulder arthroplasty system
Medacta Shoulder SystemDevice
Anatomic total shoulder arthroplasty system - standard configuration
| Study group | Role | What they receive |
|---|---|---|
| Mirror group | Experimental | Mirror Medacta Shoulder System Receives: Device: Mirror Medacta Shoulder System |
| Historical Control group | Active comparator | Total shoulder arthroplasty system Receives: Device: Medacta Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
0 (worst) - 48 (best)
Measured: 12 months
Secondary outcomes (5)
Device Success Rate
Kaplan Meier survival curve, examining the following end-points:
- component revision for any reason;
- aseptic loosening;
- any definite change in the position of components.
Measured: 24 months
Oxford Shoulder Score
0 (worst) - 48 (best)
Measured: 24 months
Constant score
0(worst) - 100 (best)
Measured: 24 months
Subjective Shoulder Value
0(worst) - 100 (best)
Measured: 24 months
Device parameters
Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
- Radiolucencies,
- Migration,
- Osteolysis,
- Subsidence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start5 Jan 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis ShoulderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias A Zumstein, Prof Dr. med, Principal investigator, Lindenhofgruppe AG (Bern)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062252
- Sponsor's protocol ID
- P06.003.01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
- ClinicalTrials.gov ID
- NCT05062252
- Acronym / sponsor ID
- P06.003.01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Sep 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.
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror group | Experimental | Device: Mirror Medacta Shoulder SystemMirror Medacta Shoulder System |
| Historical Control group | Active comparator | Device: Medacta Shoulder SystemTotal shoulder arthroplasty system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 yr
- Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
- Willingness and ability to comply with study protocol
Key exclusion criteria (18 listed)
- Medical condition or balance impairment that could lead to falls
- Prior rotator cuff surgery
- Cuff tear arthropathy/insufficient rotator cuff
- Insufficient bone quality which may affect the stability of the implant
- Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
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 |
|---|---|---|
| Mirror Medacta Shoulder SystemAnatomic total shoulder arthroplasty system | Device | Mirror group |
| Medacta Shoulder SystemAnatomic total shoulder arthroplasty system - standard configuration | Device | Historical Control group |
Primary outcome
Oxford Shoulder Score
Time frame: 12 months
0 (worst) - 48 (best)
5 secondary outcomes
Device Success Rate
Time frame: 24 months
Oxford Shoulder Score
Time frame: 24 months
Constant score
Time frame: 24 months
Subjective Shoulder Value
Time frame: 24 months
Device parameters
Time frame: 24 months
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 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Arthritis Shoulder
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
Enrolling by invitationPhase 1
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Rotator Cuff Tears, Rotator Cuff Injuries
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 A Zumstein, Prof Dr. med principal investigator
Lindenhofgruppe AG (Bern)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Medacta Shoulder System and Medacta Shoulder System in people with Arthritis Shoulder and Post-traumatic Arthrosis of Other Joints, Upper Arm, run by Medacta International SA at 2 sites in Switzerland.
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 18 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Oxford Shoulder Score (time frame: 12 months). 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 7 Oct 2026.