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Affixus Natural Nail System for Humeral Fractures

This study is looking at the Affixus Natural Nail System Humeral Nail, a device used to fix broken bones in the upper arm (humerus). It's for people aged 18 or older who have a fracture in their upper arm bone that needs surgery and can be treated with this specific nail system. The main goal is to see if the bone heals (bone union) 12 months after surgery. Researchers will also check for any problems (adverse events) and how well your arm works (functional outcome) and your quality of life. This is an observational study, meaning researchers will gather information from patients who are already receiving this treatment.

Study design
This is an observational study aiming to enroll 100 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess bone union.

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NCT05019664

Affixus Natural Nail System Humeral Nail PMCF

Active, Not Recruiting
Not specifiedAges 18+Observational
Zimmer Biomet
~100 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:humeral fracture

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bone Union
Measured over 12 months

Conditions

Humeral Fractures, Proximal
Humeral Fractures

Explore related trials

Humerus Fracture

Where it's being run

5 sites across 5 states
Texas1
Belgium1
Valladolid1
Spain1
Thurgau1

Study leadership

  • Emilie Rohmer, MSc. · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Bone Union12 months

    The primary endpoint is bone union after 12 months since surgery. (Bone union defined as no pain or tenderness at the site, and strong enough to allow normal activities.)