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Upper arm fracture nail system put to the test in 100-patient study

NCT ID NCT05019664

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 checks how well a commercially available nail system works for fixing broken upper arm bones. 100 adults who need surgery for a humerus fracture will be followed for 12 months to see if the bone heals enough for normal activities. The goal is to confirm the device is safe and helps patients regain arm function.

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 100 people

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

Started

Aug 2022

Expected to finish

Aug 2027

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

Consecutive series of 100 subjects globally implanted with the Affixus Natural Nail System Humeral Nail for temporary fixation and stabilization of fractures or osteotomies of the humerus.

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: * Patients 18 years or older and skeletally mature. * Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing. * Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail. * 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. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.) * Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study. Exclusion Criteria: * Distal fracture involving the olecranon fossa. * Bone shaft having excessive bow or deformity. * A medullary canal obliterated by a previous fracture or tumor. * Active or previous infection. * Skeletally immature patients. * All concomitant diseases that can impair the functioning and the success of the implant. * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant). * Patient known to be pregnant or breast feeding. * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). * Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study. * Not expected to survive the duration of the follow-up program.

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Conditions

The condition(s) this trial relates to.

humerus fracture Shoulder Fractures

As listed by the trial registrant

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

Contacts and locations

Locations

  • General Foundation of the University of Valladolid

    Valladolid, Valladolid, 47002, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Kantonsspital Frauenfeld

    Frauenfeld, Thurgau, 8501, Switzerland

  • UZ Leuven - Traumatology Department

    Leuven, 3000, Belgium

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.