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

Study Overview
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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.

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

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

Conditions
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Femoral Neck Fracture, Hip Fracture

Intervention / Treatment
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* Device: FNS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Femoral Neck Fractures AO/OTA 31-B1:3<br>Fixation using the implant FNS. | Device: FNS<br>* Surgical intervention using the FNS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications within the first 3 months after surgery |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, femoral neck, Garden classification, healing, cut-out, iatrogenic fracture, implant, rotational stability, minimal invasive