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Affixus Natural Nail System Humeral Nail PMCF

NCT05019664 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Humeral Fractures, Proximal
  • Humeral Fractures

Interventions

DEVICE

humeral fracture

Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer, MSc. · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-29
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019664 on ClinicalTrials.gov