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

Hip Fracture Clinical Trial

— FR_FNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422355
• Other study ID #: FR FNS
• Status: Completed
• Start date: September 30, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Device:
• FNS
Surgical intervention using the FNS

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck	Tirol
Germany	Friedrich-Schiller-Universität Jena	Jena	Thüringen
Germany	Ulm University	Ulm	Baden-Württemberg
Switzerland	Kantonsspital Baselland	Bruderholz	BL
Switzerland	Ospedale Regionale di Lugano	Lugano	Ticino
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Stadtspital Triemli	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications within the first 3 months after surgery		3 months
Secondary	Fracture mechanism	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	Pre-operatively (Day -1)
Secondary	Classification of the fracture	Classification of the fracture using the Garden classification and the AO/AOTA classification	Pre-operatively (Day -1)
Secondary	Time from injury to surgery	Time in hours from the injury to the start of the surgery	Surgery (Day 0)
Secondary	Length of surgery	Time in minutes from first incision to closure	Surgery (Day 0)
Secondary	Harris Hip Score		Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Secondary	EQ5D-5L		Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Secondary	Radiological bone union (RUSH score)	RUSH score	6 weeks, 3 months, 6 months and 12 months after surgery
Secondary	Quality of reduction (Garden's alignment index and Lowell's criteria)	Garden's alignment index and Lowell's criteria	Surgery (Day 0)

External Links

•   Sponsor's website