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New study confirms shoulder fracture hardware holds up

NCT ID NCT03626038

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a metal plate and screw system used to fix certain types of broken upper arm bones. About 135 adults who need surgery for a fresh fracture or one that didn't heal with a cast will be followed for one year. The main goal is to see how often a second surgery is needed because the hardware causes problems.

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

135 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Dec 2026

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.

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 be 18 years of age or older. * Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws. * Patients with failed conservative treatment within 3 weeks since injury. * Patient must be able and willing to complete the protocol required follow-up. * Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. * Patient must be in a good nutritional state Exclusion Criteria: * Delay of surgery for more than 3 weeks. * Tumor induced fractures * Patient is a prisoner. * Pregnancy/ breast feeding * Patient is a current alcohol or drug abuser. * Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program. * Patient has an active infection. * Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock. * Patient is sensitive to foreign body material.

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Conditions

The condition(s) this trial relates to.

humerus fracture injury osteoarthritis psoriatic arthritis rheumatoid arthritis Shoulder Fractures

As listed by the trial registrant

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

Osteoarthritis Post traumatic arthritis Proximal humeral fracture Psoriatic arthritis Rheumatoid arthritis

Contacts and locations

Locations

  • Bone and Motion Training and Research Foundation

    Granges-Paccot, Granges-Paccot, 1763, Switzerland

  • Foundation for Orthopaedic Research & Education

    Tampa, Florida, 33637, United States

  • Hallym University Kangnam Sacred Hearth Hospital

    Seoul, Seoul, 07441, South Korea

  • Inje University Seoul Paik Hospital

    Seoul, Seoul, 07441, South Korea

  • Korea University Anam Hospital

    Seoul, Seoul, 02841, South Korea

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • The Research Institute of McGill University Health Centre

    Montreal, Quebec, H3G 1A4, Canada

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