Can personalized surgery planning improve shoulder replacement outcomes?

NCT ID NCT05615259

Symptom relief Sponsor: Exactech Source: ClinicalTrials.gov ↗

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers compare two ways to plan reverse shoulder replacement surgery: Exactech Guided Personalized Surgery (GPS) and conventional instruments. The study enrolls adults scheduled for reverse shoulder arthroplasty and follows them for at least two years, with long-term follow-up up to ten years. The main goal is to see whether GPS places the implant more accurately, and whether that affects range of motion and patient-reported shoulder function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Guided Personalized Surgery (GPS) planning for reverse shoulder replacement
What this could lead to: If personalized planning places the shoulder implant more accurately, patients could gain better range of motion and shoulder function after surgery.
What could go wrong: This is a comparison of two surgical planning methods, not a new drug, and any advantage may be small or fade over time. Surgery itself carries risks such as infection, implant loosening, or nerve injury.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

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 who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years

Ages

21 years and older

Sex

Anyone

Healthy volunteers

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

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 at least 21 years of age at the time of surgery * Patient is indicated for reverse shoulder arthroplasty * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years) * Patient is willing and able to review and sign a study informed consent form * Preop CT scan is within 3 months of the date of surgery Exclusion Criteria: * Revision shoulder arthroplasty * Reverse shoulder arthroplasty for fracture * Need for structural glenoid bone graft * Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Neuromuscular disorders that do not allow control of the joint * Significant injury to the brachial plexus * Non-functional deltoid muscles * The patient is unwilling or unable to comply with the post-operative care instructions * Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes. * 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 who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Comparison Technology

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
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.

Can personalized surgery planning improve shoulder replacement outcomes?

What the study statuses mean