Evaluation of the Affixus Natural Nail System for treating humeral fractures
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)
Zimmer Biomet · NCT05019664
This study is testing a new nail system to see if it safely helps people heal from shoulder and arm fractures and improves their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet (industry) |
| Locations | 5 sites (San Antonio, Texas and 4 other locations) |
| Trial ID | NCT05019664 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to confirm the safety and performance of the Affixus Natural Nail System for treating proximal and humeral shaft fractures. It is an observational, prospective study that will analyze adverse events, fracture healing, and functional outcomes in patients treated with this system. The primary endpoint is to assess bone union after 12 months, while secondary endpoints include evaluating functional outcomes and quality of life. Participants will be monitored for adverse events related to the implant and surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older with proximal or humeral shaft fractures requiring surgical intervention.
Not a fit: Patients with distal fractures involving the olecranon fossa or excessive bow/deformity of the bone shaft may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with humeral fractures.
How similar studies have performed: Other studies have shown success with similar intramedullary nailing approaches for humeral fractures, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Antonio, Texas and 4 other locations
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)
- UZ Leuven - Traumatology Department — Leuven, Belgium (RECRUITING)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
- General Foundation of the University of Valladolid — Valladolid, Spain (RECRUITING)
- Kantonsspital Frauenfeld — Frauenfeld, Thurgau, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Kristopher Krajewski, B.A.
- Email: kristopher.krajewski@zimmerbiomet.com
- Phone: +41 79 396 94 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Humeral Fractures, Proximal, Humeral Fractures