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
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.
Description
Study objective: The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the Affixus Natural Nail System Humeral Nail and its instrumentation by analyzing adverse event records, fracture/osteotomy healing and functional outcome and adverse events. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The performance and clinical benefits will be evaluated by…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 formall…
Interventions
- Devicehumeral fracture
Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
Locations (5)
- University of Texas Health Science Center at San AntonioSan Antonio, Texas
- UZ Leuven - Traumatology DepartmentLeuven
- Hospital de la Santa Creu i Sant PauBarcelona
- General Foundation of the University of ValladolidValladolid
- Kantonsspital FrauenfeldFrauenfeld, Thurgau