NCT02422355

A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.

Detailed description

All patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. Data of a visit after 6 months and 12 months are collected if bone union according to the RUSH score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site. Preoperative: * Patient details * Fracture Classification and comminution based on CT * Pre-fracture HHS and EQ5D * X-rays Intraoperative: * Surgery details * Defined intraoperative complications * Intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement Postoperative: * X-ray prior to any mechanical load: hip ap (with leg 15° internally rotated) and lateral 6 weeks and 3 months FU: * Defined postoperative complications * HSS and EQ5D * X-rays

Conditions

• Femoral Neck Fracture
• Hip Fracture

Interventions

Type	Name	Description
DEVICE	FNS	Surgical intervention using the FNS

Timeline

• Start date: 2017-09-30
• Primary completion: 2020-11-30
• Completion: 2021-12-31
• First posted: 2015-04-21
• Last updated: 2023-01-31

Locations

7 sites across 3 countries: Austria, Germany, Switzerland