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

Completed

• Conditions: Femoral Neck Fracture; Hip Fracture
• Interventions: Device: FNS

• Registration Number: NCT02422355
• Lead Sponsor: AO Innovation Translation Center

Brief 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

Study Timeline

• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Study Start: 2017-09-30
• Primary Completion: 2020-11-30
• Status Verified: 2021-12
• Study Completion: 2021-12-31
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Age 18 years and older
• Diagnosis of a medial femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
• Ability to understand the content of the patient information/Informed Consent Form
• Willingness and ability to participate in the registry according to the Registry Plan (RP)
• Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria

• Pathological fracture
• Additional acute fracture
• Any not medically managed severe systemic disease
• Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the registry period
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Femoral Neck Fractures AO/OTA 31-B1:3	FNS	Fixation using the implant FNS.

Primary Outcome Measures

Name	Time	Method
Number of complications within the first 3 months after surgery	3 months

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Time from injury to surgery	Surgery (Day 0)	Time in hours from the injury to the start of the surgery
EQ5D-5L	Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Classification of the fracture	Pre-operatively (Day -1)	Classification of the fracture using the Garden classification and the AO/AOTA classification
Quality of reduction (Garden's alignment index and Lowell's criteria)	Surgery (Day 0)	Garden's alignment index and Lowell's criteria
Fracture mechanism	Pre-operatively (Day -1)	Classification of the fracture mechanism in one of the following group: Fall from standing height , Falls from elevated height, Road traffic accident or Other causes
Length of surgery	Surgery (Day 0)	Time in minutes from first incision to closure
Radiological bone union (RUSH score)	6 weeks, 3 months, 6 months and 12 months after surgery	RUSH score

Trial Locations

Locations (7)

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria

Ulm University; 🇩🇪 Ulm, Baden-Württemberg, Germany

Friedrich-Schiller-Universität Jena; 🇩🇪 Jena, Thüringen, Germany

Kantonsspital Baselland; 🇨🇭 Bruderholz, BL, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Ticino, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland