Actively Recruiting
Affixus Natural Nail System Humeral Nail PMCF
Led by Zimmer Biomet · Updated on 2025-11-12
100
Participants Needed
5
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Affixus Natural Nail System Humeral Nail PMCF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older and skeletally mature.
- Have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and eligible for fixation by intramedullary nailing.
- Have been or are scheduled to be treated with the Affixus Natural Nail System Humeral Nail.
- Able and willing to complete the protocol required follow-up.
- Have signed Institutional Review Board/Ethics Committee approved informed consent.
- Capable of understanding surgeon's explanations, following instructions, willing to participate in follow-up.
You will not qualify if you...
- Distal fracture involving the olecranon fossa.
- Bone shaft with excessive bow or deformity.
- Medullary canal obliterated by previous fracture or tumor.
- Active or previous infection.
- Skeletally immature patients.
- Concomitant diseases impairing implant function or success.
- Mental or neurologic conditions preventing informed consent or postoperative care adherence.
- Vulnerable subjects (prisoners, mentally incompetent, known substance abusers, or anticipated non-compliant).
- Known pregnancy or breastfeeding.
- Likely problems maintaining follow-up (no fixed address, long distance, plans to move).
- Any condition placing patient at undue risk or interfering with study as judged by investigator.
- Not expected to survive duration of follow-up program.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
2
UZ Leuven - Traumatology Department
Leuven, Belgium, 3000
Actively Recruiting
3
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
4
General Foundation of the University of Valladolid
Valladolid, Spain, 47002
Actively Recruiting
5
Kantonsspital Frauenfeld
Frauenfeld, Thurgau, Switzerland, 8501
Actively Recruiting
Research Team
K
Kristopher Krajewski, B.A.
CONTACT
R
Richard J Marek, B.A.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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