Can metal plates restore shoulder function after a bad break?
NCT ID NCT05703958
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are collecting data on people who receive Equinoxe proximal humerus fracture plates, a type of hardware used to repair broken upper arm bones near the shoulder. The study follows participants for up to 10 years after surgery, tracking shoulder motion, pain, and daily function through standard questionnaires. The goal is to understand how well the plates perform and hold up over time in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Equinoxe Proximal Humerus Fracture Plate, a metal plate and screws used to repair broken upper arm bones near the shoulder
- What this could lead to
- If the plates hold up well, doctors could have clearer long-term evidence on how well this hardware restores shoulder movement and eases pain after a serious shoulder fracture.
- What could go wrong
- This is an observational study, not a controlled experiment, so it cannot prove the plate causes better outcomes. Results may not apply to all patients, and some people may still have stiffness, pain, or need further surgery.
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 151 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Sep 2034
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
Patients undergoing ORIF surgery who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
- Ages
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21 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: * Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing to agree to be followed for up to 10 years following their index surgery * Patient is willing and able to review and sign a study informed consent form Exclusion Criteria: * Osteomyelitis of the proximal humerus or scapula * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * The patient is unwilling or unable to comply with the post-operative care instructions * Alcohol, drug, or other subtance abuse * Any disease state that could adversaly affect the function or longevity of the implant * Patient is pregnant * Patient is a prisoner * Patient has a physical or mental condition that would invalidate the results
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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NYU Grossman School of Medicine
RECRUITINGNew York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New nerve block technique aims to protect breathing in elderly shoulder surgery patients
- Shoulder fracture surgery under the microscope: new study tracks recovery
- Can 3D scans improve shoulder fracture diagnosis?
- Shoulder replacement or not? new study for seniors with complex fractures
- New study confirms shoulder fracture hardware holds up
- Shoulder implant under review: will it last 10 years?