Affixus Natural Nail System Humeral Nail PMCF

Launched by ZIMMER BIOMET · Aug 20, 2021

Keywords

ClinConnect Summary

The Affixus Natural Nail System Humeral Nail clinical trial is studying a special implant used to treat fractures in the upper arm (humerus). The goal is to confirm that this implant is safe and effective for patients who need surgery for their humeral fractures. They are currently looking for participants who are 18 years or older and have specific types of arm fractures that require a surgical procedure using the Affixus Natural Nail System. To join the study, patients need to be able to follow the doctor's instructions and complete the required follow-up visits after surgery.

If you decide to participate, you will receive the Affixus Natural Nail implant and be monitored to see how well it works and how safe it is for you. It’s important to note that some individuals may not be eligible to participate, such as those with certain medical conditions or previous infections. The study has been approved by a group that ensures the safety and rights of participants, so your well-being is a priority throughout the process.

Gender

ALL

Eligibility 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.