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Completed

NCT Number: NCT02422355

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

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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Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fracture Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Innsbruck, Tyrol, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FNS

Device

Surgical intervention using the FNS

Primary outcomes

  1. Number of complications within the first 3 months after surgery

    Time frame: 3 months

Secondary outcomes

  1. Fracture mechanism

    Time frame: Pre-operatively (Day -1)

    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

  2. Classification of the fracture

    Time frame: Pre-operatively (Day -1)

    Classification of the fracture using the Garden classification and the AO/AOTA classification

  3. Time from injury to surgery

    Time frame: Surgery (Day 0)

    Time in hours from the injury to the start of the surgery

  4. Length of surgery

    Time frame: Surgery (Day 0)

    Time in minutes from first incision to closure

  5. Harris Hip Score

    Time frame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery

  6. EQ5D-5L

    Time frame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery

  7. Radiological bone union (RUSH score)

    Time frame: 6 weeks, 3 months, 6 months and 12 months after surgery

    RUSH score

  8. Quality of reduction (Garden's alignment index and Lowell's criteria)

    Time frame: Surgery (Day 0)

    Garden's alignment index and Lowell's criteria

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Acronym: FR_FNS

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2015
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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