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

AO Innovation Translation Center

Status: Completed

Conditions: Hip Fracture; Femoral Neck Fracture

Treatments: Device: FNS

Study type: Observational

Funder types: Other

Identifiers

NCT02422355

FR FNS

Details and patient eligibility

About

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.

Full 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

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 1 patient group

Femoral Neck Fractures AO/OTA 31-B1:3

Description:

Fixation using the implant FNS.

Treatment:

Device: FNS