Shoulder ArthroplastyNCT07812324
A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System
A study testing Mirror Anatomic Total Shoulder Prosthesis and Medacta Anatomic Shoulder in people with Shoulder Arthroplasty and Total Shoulder Arthroplasty, run by Medacta USA at 12 sites in United States.
Trial summary
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Shoulder Arthroplasty, Total Shoulder Arthroplasty
- What is being tested?
- Mirror Anatomic Total Shoulder Prosthesis and Medacta Anatomic Shoulder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2026to Dec 2029
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject 22 years or older
- Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis.
- Scapula and proximal humerus must have reached skeletal maturity
- Willing and able to comply with the protocol
- Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
Who cannot join
- Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as:
- Rapid joint destruction, marked bone loss or bone resorption;
- Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
- Osteomalacia
- osteoporosis
- rheumatoid arthritis
Show all 37Show fewer
- Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
- Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
- Infection at or near the site of implantation, including:
- Glenohumeral joint infection
- Osteomyelitis
- Distant or systemic infection
- Medical conditions or balance impairments that could lead to falls
- Prior Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
- Prior failed rotator cuff surgery, but excluding successful shoulder arthroscopy
- Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
- Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
- Metabolic disorders which may impair bone function
- Nonfunctional deltoid muscle
- Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
- Patients diagnosed with severe shoulder instability
- Patients diagnosed with subscapularis incompetence
- Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
- Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
- Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery or patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
- Female subjects who are pregnant or planning to become pregnant within the study period
- In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
- History of any cognitive or mental health status that would interfere with study participation
- Substance Use Disorder (alcohol and/or drug)
- Engages in manual labor or sports activities that could affect shoulder outcome
- Patients who have a work-related injury leading to shoulder OA
- Currently enrolled in any clinical research study that might interfere with the current study endpoints
- Patients with a life expectancy of less than three years
- Medical condition or balance impairment that could lead to falls
- Weight bearing shoulder due to wheelchair, crutches, rollator at the time of operation
- Individuals who are incarcerated or detained in a correctional facility or under any form of legal supervision that limits their ability to voluntarily consent to participate in the trial.
- Previous randomization of the subject in the current study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites
West Boca Medical Center
Boca Raton, Florida, 33428
Rosena Siquitte, rsiquitte@paleyinstitute.org
Jonathan Levy, MD
Johns Hopkins - Washington
Columbia, Maryland, 21044
Ahlam Askar, aashkar1@jh.edu
Debra Chan, dchan21@jh.edu
Central Indiana Orthopedics
Fishers, Indiana, 46037
Brian Badman, MD
OrthoArizona
Gilbert, Arizona, 85297
Nastia A, nastiaanddr@gmail.com
Austin Smith, MD
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
Meredith Yeager, meredith.yeager@andrewsref.org
Ellie Hartsfield, 448-227-7309, ellie.hartsfield@andrewsref.org
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756
Holly Symonds, holly.b.symonds@hitchcock.org
Daniel Austin, MD
Southern Oregon Orthopedics
Medford, Oregon, 97504
Lindsey Chin, lindsey.chin13@gmail.com
NormaJean Hatten, normajean@sooresearch.net
Cornell Med NY
New York, New York, 10021
Jessica Rios, riosj@hss.edu
Theodore Blaine, MD
Penn Medicine
Philadelphia, Pennsylvania, 19104
Ellen Stinger, Ellen.Stinger@Pennmedicine.upenn.edu
Warren Harding, Warren.Harding@Pennmedicine.upenn.edu
University of Utah Hospital
Salt Lake City, Utah, 84108
Emma Merril, emma.merrill@hsc.utah.edu
Ashley Neese, ashley.neese@hsc.utah.edu
Intermountain Health
St. George, Utah, 84790
Emily Piazza, emily.rossman@imail.org
Zachary Leitze, MD
Foundation for Orthopedic Research and Education
Tampa, Florida, 33607
Peter Simon, psimon@foreonline.org
Debbi Warren, dwarren@foreonline.org
About this study
Official title: Randomized, Controlled, Multi-center, Prospective Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
- Conditions
- Shoulder Arthroplasty, Total Shoulder Arthroplasty
- Being tested
- Mirror Anatomic Total Shoulder Prosthesis, Medacta Anatomic Shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Anatomic Total Shoulder ProsthesisDevice
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
Medacta Anatomic ShoulderDevice
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.
| Study group | Role | What they receive |
|---|---|---|
| 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational) | Experimental | Not described Receives: Device: Mirror Anatomic Total Shoulder Prosthesis |
| 143 patients undergoing implantation of Medacta Anatomic Shoulder (control) | Active comparator | Not described Receives: Device: Medacta Anatomic Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations.
Measured: 24 months of follow up
Secondary outcomes (1)
Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.
The secondary endpoint at 24 months will be determined at the 6-week, 6-month, and 1-year timepoints. Radiographic evaluation and assessment, a 100-point patient-reported scale used to evaluate shoulder pain and daily function, 12 questions used to measure general physical/mental health from a patient's perspective (This is evaluated 0-100), Implant survival, and Adverse Events.
Measured: 24 Months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812324
- Sponsor's protocol ID
- MUSA-MIRROR1-2026
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undetermined at this time.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multi-center, Prospective Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
- ClinicalTrials.gov ID
- NCT07812324
- Acronym / sponsor ID
- MUSA-MIRROR1-2026
- Conditions
- Shoulder Arthroplasty, Total Shoulder Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Sep 2026 (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 study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational) | Experimental | Device: Mirror Anatomic Total Shoulder Prosthesis |
| 143 patients undergoing implantation of Medacta Anatomic Shoulder (control) | Active comparator | Device: Medacta Anatomic Shoulder |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subject 22 years or older
- Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis.
- Scapula and proximal humerus must have reached skeletal maturity
- Willing and able to comply with the protocol
- Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
Key exclusion criteria (37 listed)
- Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as:
- Rapid joint destruction, marked bone loss or bone resorption;
- Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
- Osteomalacia
- osteoporosis
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 Anatomic Total Shoulder ProsthesisTotal shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface. | Device | 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational) |
| Medacta Anatomic ShoulderTotal shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. | Device | 143 patients undergoing implantation of Medacta Anatomic Shoulder (control) |
Primary outcome
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
Time frame: 24 months of follow up
The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations.
1 secondary outcome
Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.
Time frame: 24 Months of follow up
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. Undetermined at this time.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Anatomic Total Shoulder Prosthesis and Medacta Anatomic Shoulder in people with Shoulder Arthroplasty and Total Shoulder Arthroplasty, run by Medacta USA at 12 sites in United States.
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 5 inclusion and 37 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 Rena Mandino, CCRP (629-654-0697, rmandino@medacta.us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint (time frame: 24 months of follow up). 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 16 Sep 2026.