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Recruiting NCT05019664

Affixus Natural Nail System Humeral Nail PMCF

Trial Parameters

Condition Humeral Fractures, Proximal
Sponsor Zimmer Biomet
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-08-29
Completion 2027-08
Interventions
humeral fracture

Brief 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.

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 m

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