NCT03807349

N-Force Screws Augmented With N-Force Blue in Hip Fractures

N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.

Detailed description

Primary Endpoint: • Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Secondary Endpoints: * Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction. * Cost effectiveness

Conditions

• Intracapsular Proximal Femur Fracture
• Garden Grade I Subcapital Fracture of Femoral Neck
• Garden Grade II Subcapital Fracture of Femoral Neck

Interventions

Type	Name	Description
DEVICE	N-Force Screws Augmented with N-Force Blue	N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)

Timeline

• Start date: 2019-02-21
• Primary completion: 2021-03-11
• Completion: 2021-03-11
• First posted: 2019-01-16
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study