Elbow implant showdown: which design works best?

NCT ID NCT07560657

Disease control Sponsor: Hospital Universitario La Paz Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of artificial elbow joints used to replace a broken bone in the elbow that can't be fixed. About 90 patients will be randomly assigned to receive one of two implant designs. Researchers will track their elbow function, pain, and movement for two years to see if one design leads to better results.

What this could mean

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

Active substance: radial head arthroplasty (implant)
What this could lead to: If this trial succeeds, it could help surgeons choose the best implant design for patients with severe elbow fractures, improving mobility and reducing complications.
What could go wrong: This is a small, early-stage trial with only 90 patients. Results may not apply to everyone, and some patients may still experience stiffness or need implant removal.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Started

Apr 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Age over 18 years * Acute, non-reconstructable radial head fracture scheduled for radial head replacement. * Able to understand the informed consent and patient information sheet and provide written consent. * Able to and compliant with the planned clinical follow-up: at 6 weeks, 3 months, 6 months, 12 months, and 24 months. * Underwent acute surgery, excluding treatment for sequelae. * Radial head replacement using either of the two study designs. Exclusion Criteria: * Previous elbow surgeries or ligamentous or bone injuries managed conservatively. * Medical contraindications for surgery. * Medical comorbidities that may interfere with rehabilitation or participation in the study: advanced osteoarthritis, associated chondral lesions, advanced rheumatoid arthritis, neuromuscular or neurovascular disorders, chronic infections or immunodeficiencies, advanced cardiovascular, renal, or pulmonary disease, concurrent or past cancer * Allergy or contraindication to the use of prosthesis materials.

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Conditions

The condition(s) this trial relates to.

arthropathy Elbow Fractures Elbow Injuries radius fracture

As listed by the trial registrant

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

Elbow arthropathy Elbow dislocation Elbow fracture Elbow fractures involving A combination of fractures of the radius and uln Elbow injury

Elbow implant showdown: which design works best?

What the study statuses mean