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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Femoral Neck Fracture Hip Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Femoral Neck Fractures AO/OTA 31-B1:3

Fixation using the implant FNS.

FNS

Intervention Type DEVICE

Surgical intervention using the FNS

Interventions

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FNS

Surgical intervention using the FNS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No