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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture; Femoral Neck Fracture
• Intervention / Treatment: Device: FNS

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Universität Innsbruck
• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89081
      • Ulm University
  • Thüringen
    • Jena, Thüringen, Germany, 07740
      • Friedrich-Schiller-Universitat Jena
• Switzerland
  • Luzern, Switzerland, 6006
    • Luzerner Kantonsspital
  • Zürich, Switzerland, 8063
    • Stadtspital Triemli
  • BL
    • Bruderholz, BL, Switzerland, 4401
      • Kantonsspital Baselland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Ospedale Regionale di Lugano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from a femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Femoral Neck Fractures AO/OTA 31-B1:3; Fixation using the implant FNS.	Device: FNS; Surgical intervention using the FNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Karl Stoffel, Prof, Kantonsspital Baselland

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: hip; implant; healing; minimal invasive; femoral neck; Garden classification; cut-out; iatrogenic fracture; rotational stability
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: FR FNS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No