Cuff Tear ArthropathyNCT05128500
Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
An observational study of Cuff Tear Arthropathy and Primary Osteoarthritis, run by Permedica spa at 4 sites in 3 countries.
Trial summary
This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis
- What is being tested?
- Total Shoulder Arthroplasty with Permedica's MIRAI
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 12 Jul 2019to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who are about to undergo a primary total shoulder arthroplasty in daily clinical practice, referring to one of the project investigator at the study site will be proposed to partecipate to the study.
Who may be able to join
- both genders
- at least 18 years old of age
- undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed).
- Signed informed consent
Who cannot join
- Patients requiring a revision shoulder arthroplasty
- Persistent chronic or acute infections and all septic conditions
- Persistent osteomyelitis local or systemic
- Allergy or hypersensitivity to the substances contained in the materials of the implanted components
- Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle
- Inadequate bone structure which cannot guarantee stability to the prosthetic components
Show all 16Show fewer
- Several vascular, nerve or muscular disorders, which compromise related extremities
- Marked osteoporosis, osteomalacia
- Hypotrophy of the periarticular soft tissues
- Dysmetabolic diseases such as, for example, kidney failure or systemic diseases
- Muscular insufficiency
- Active neoplastic or metastatic diseases
- Any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability
- Patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits
- Women in pregnancy, childbearing potential or breastfeeding
- Involvement in other ongoing studies or clinical trial.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
go:h - Gelenkchirurgie Orthopädie: Hannover
Hanover
Krankenhaus Reinbek St. Adolf-Stilt
Reinbek
Italy1 site
ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre
Feltre, 32032
About this study
Official title: Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study
This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Patients requiring a revision shoulder arthroplasty will not be enrolled.
The effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. The incidence of complications, adverse and serious adverse events will also be studied. Additional study aim is to evaluate a medium/long term survival of the prosthesis.
The duration of the study per single subject is 5 years.
- Conditions
- Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis, Shoulder Osteoarthritis, Rheumatoid Arthritis Shoulder, Psoriatic Arthritis
- Being tested
- Total Shoulder Arthroplasty with Permedica's MIRAI
- Keywords
- Total Shoulder Arthroplasty, Shoulder Prosthesis, Observational Study, Cuff Tear Arthropathy, Shoulder Osteoarthritis
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Arthritis, Psoriatic, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Shoulder Arthroplasty with Permedica's MIRAIProcedure or surgery
Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome: Change of shoulder function
Change of "American Shoulder and Elbow Surgeons" (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.
Measured: 5 years
Clinical outcome: Change of shoulder function
Change of "Disabilities of the Arm, Shoulder and Hand" (DASH) Score. A higher score indicates greater disability. DASH disability/symptom score = [(sum of n responses) - 1]/n x 25, where n is equal to the number of completed responses.
Measured: 5 years
Clinical outcome: Change of shoulder function
Change of Constant Score. Total score 0-100 Constant points, 0 = worse outcome and functional loss/disability; 100 = better outcome, shoulder function improvement.
Measured: 5 years
Clinical outcome: Change of shoulder function
Change of active Range of Motion (ROM)
Measured: 5 years
Secondary outcomes (5)
Radiological outcome: Radiological implant stability
Presence of Radiolucent Lines and other radiological signs of instability
Measured: 5 years
Radiological outcome: Radiological implant stability
Presence of Radiolucent Lines and other radiological signs of instability
Measured: 2 years
Safety Outcome
Incidence of adverse events and complications
Measured: 5 years
Implant survival rate
Rate of revisions. Survival estimated with Kaplan-Meier method.
Measured: 5 years
Implant survival rate
Implant failures. Survival estimated with Kaplan-Meier method.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start12 Jul 2019
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Tear ArthropathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Permedica spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Banci, Study director, Permedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128500
- Sponsor's protocol ID
- MIRAI CLH-1
- Status last verified
- Aug 2025
- First submitted
- 9 Nov 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study
- ClinicalTrials.gov ID
- NCT05128500
- Acronym / sponsor ID
- MIRAI CLH-1
- Conditions
- Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis, Shoulder Osteoarthritis, Rheumatoid Arthritis Shoulder, Psoriatic Arthritis
- Keywords
- Total Shoulder Arthroplasty, Shoulder Prosthesis, Observational Study, Cuff Tear Arthropathy, Shoulder Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Permedica spaIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 22 Nov 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 observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Patients requiring a revision shoulder arthroplasty will not be enrolled.
The effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. The incidence of complications, adverse and serious adverse events will also be studied. Additional study aim is to evaluate a medium/long term survival of the prosthesis.
The duration of the study per single subject is 5 years.
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 who are about to undergo a primary total shoulder arthroplasty in daily clinical practice, referring to one of the project investigator at the study site will be proposed to partecipate to the study.
Key inclusion criteria (4 listed)
- both genders
- at least 18 years old of age
- undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed).
- Signed informed consent
Key exclusion criteria (16 listed)
- Patients requiring a revision shoulder arthroplasty
- Persistent chronic or acute infections and all septic conditions
- Persistent osteomyelitis local or systemic
- Allergy or hypersensitivity to the substances contained in the materials of the implanted components
- Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle
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 |
|---|---|---|
| Total Shoulder Arthroplasty with Permedica's MIRAITotal Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System | Procedure or surgery | – |
Primary outcome
Clinical outcome: Change of shoulder function
Time frame: 5 years
Change of "American Shoulder and Elbow Surgeons" (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.
Clinical outcome: Change of shoulder function
Time frame: 5 years
Change of "Disabilities of the Arm, Shoulder and Hand" (DASH) Score. A higher score indicates greater disability. DASH disability/symptom score = [(sum of n responses) - 1]/n x 25, where n is equal to the number of completed responses.
Clinical outcome: Change of shoulder function
Time frame: 5 years
Change of Constant Score. Total score 0-100 Constant points, 0 = worse outcome and functional loss/disability; 100 = better outcome, shoulder function improvement.
Clinical outcome: Change of shoulder function
Time frame: 5 years
Change of active Range of Motion (ROM)
5 secondary outcomes
Radiological outcome: Radiological implant stability
Time frame: 5 years
Radiological outcome: Radiological implant stability
Time frame: 2 years
Safety Outcome
Time frame: 5 years
Implant survival rate
Time frame: 5 years
Implant survival rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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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.
Lorenzo Banci study director
Permedica
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cuff Tear Arthropathy and Primary Osteoarthritis, run by Permedica spa at 4 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 2 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 4 sites in Germany, Italy, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcome: Change of shoulder function (time frame: 5 years). The study lists 4 primary outcomes in all. 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 2 Sep 2025.