Can a new shoulder implant restore arm function where others fail?
NCT ID NCT07764614
First seen Aug 14, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study is following people who receive a Tornier Perform™ Reversed MonoPost shoulder replacement to see how well it works and how safe it is. The implant is designed for patients with severe shoulder damage, such as from arthritis, fractures, or failed previous surgeries. Researchers will measure changes in shoulder function and pain over time. The goal is to confirm the device's real-world performance in a larger group of patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tornier Perform™ Reversed MonoPost shoulder replacement system
- What this could lead to
- If successful, this could confirm the device as a reliable option for improving shoulder function and reducing pain in people with severe shoulder damage.
- What could go wrong
- This is an observational follow-up study, not a randomized trial, so results may be influenced by patient selection. As with any shoulder replacement, risks include implant loosening, infection, or limited improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Approximately 150 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria. No specific methods (such as randomization, blinding or stratification) for assigning participants are used in this protocol. Consecutive participants at each site meeting all of the eligibility criteria will be considered for enrollment in this study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years or older at the time of the informed consent. * Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC). * Willing and able to comply with the requirements of the study protocol * Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fracture of the Humeral Head * Traumatic arthritis * Revision of the devices if sufficient bone stock remains * Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM. Exclusion Criteria: * Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity). * Participation in the treatment period of another clinical trial during the clinical investigation. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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