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Elbow implant under the microscope: will it last?

NCT ID NCT05583448

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well the ExploR Radial Head implant works over time for people who had elbow replacement surgery after an injury. Researchers will track about 93 patients to see how long the implant lasts and if any problems arise. The goal is to confirm the device is safe and helps patients use their arm better.

What this could mean

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

Active substance
ExploR Radial Head implant (a metal device to replace the radial head in the elbow)
What this could lead to
If successful, this study could confirm that the ExploR Radial Head implant is safe and works well over the long term for people with elbow injuries.
What could go wrong
This is a small, observational study with no control group, so results may not apply to everyone. The implant could still fail or cause complications over time.

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

About 93 people

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

Started

Aug 2022

Expected to finish

Jul 2035

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

The study population should be a consecutive series of subjects implanted with the ExploR Radial Head System. The aim is to include 93 radial head arthroplasty procedures in the study.

Ages

18 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 must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following: * Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment * Primary replacement after fracture of the radial head * Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions. Exclusion Criteria: * Infection * Sepsis * Osteomyelitis * Uncooperative patient or patient with neurological disorders who are incapable of following directions * Osteoporosis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent * Patient is known to be pregnant or breastfeeding. * Patient is unwilling to sign informed consent.

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Conditions

The condition(s) this trial relates to.

Elbow Injuries osteoarthritis radius fracture

As listed by the trial registrant

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

Elbow injury

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Norton Healthcare

    Louisville, Kentucky, 40241, United States

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