NCT05019664

Affixus Natural Nail System Humeral Nail PMCF

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects. Study Endpoints: Primary endpoint: The primary endpoint is bone union after 12 months since surgery. Secondary endpoint: The secondary endpoints will be evaluating functional outcomes (Range of Motion, \& American Shoulder and Elbow Surgeons questionnaire), quality of life questionnaire (EQ-5D-5L), radiographic findings and adverse events including re-operation of all enrolled study subjects at the defined follow up time points.

Conditions

• Humeral Fractures, Proximal
• Humeral Fractures

Interventions

Type	Name	Description
DEVICE	humeral fracture	Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.

Timeline

• Start date: 2022-08-29
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2021-08-25
• Last updated: 2025-11-12

Locations

5 sites across 4 countries: United States, Belgium, Spain, Switzerland

Regulatory

• FDA-regulated device study