Affixus Natural Nail System Humeral Nail PMCF

Running, not enrolling

Conditions studied: Humeral Fractures, Proximal, Humeral Fractures

In brief

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Key facts

Study ID

NCT05019664

Run by

Zimmer Biomet

People needed

100

Starts

2022-08-29

Expected to finish

2027-08-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• UZ Leuven - Traumatology Department — Leuven, Belgium
• General Foundation of the University of Valladolid — Valladolid, Valladolid, Spain
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Kantonsspital Frauenfeld — Frauenfeld, Thurgau, Switzerland

Full record on ClinicalTrials.gov

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