NCT02422355

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 31, 2023

Status Verified

December 1, 2021

Enrollment Period

3.2 years

First QC Date

March 27, 2015

Last Update Submit

January 30, 2023

Conditions

Femoral Neck FractureHip Fracture

Keywords

hipfemoral neckGarden classificationhealingcut-outiatrogenic fractureimplantrotational stabilityminimal invasive

Outcome Measures

Primary Outcomes (1)

  • Number of complications within the first 3 months after surgery

    3 months

Secondary Outcomes (8)

  • Fracture mechanism

    Pre-operatively (Day -1)

  • Classification of the fracture

    Pre-operatively (Day -1)

  • Time from injury to surgery

    Surgery (Day 0)

  • Length of surgery

    Surgery (Day 0)

  • Harris Hip Score

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

  • +3 more secondary outcomes

Study Arms (1)

Femoral Neck Fractures AO/OTA 31-B1:3

Fixation using the implant FNS.

Device: FNS

Interventions

FNSDEVICE

Surgical intervention using the FNS

Femoral Neck Fractures AO/OTA 31-B1:3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Ulm University

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Friedrich-Schiller-Universität Jena

Jena, Thuringia, 07740, Germany

Location

Kantonsspital Baselland

Bruderholz, Basel-Landschaft, 4401, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6006, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Related Publications (1)

  • Stoffel K, Michelitsch C, Arora R, Babst R, Candrian C, Eickhoff A, Gebhard F, Platz A, Schmid FA, Weschenfelder W, Sommer C. Clinical performance of the Femoral Neck System within 1 year in 125 patients with acute femoral neck fractures, a prospective observational case series. Arch Orthop Trauma Surg. 2023 Jul;143(7):4155-4164. doi: 10.1007/s00402-022-04686-w. Epub 2022 Dec 2.

    PMID: 36460761DERIVED

Related Links

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Karl Stoffel, Prof

    Cantonal Hosptal, Baselland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 21, 2015

Study Start

September 30, 2017

Primary Completion

November 30, 2020

Study Completion

December 31, 2021

Last Updated

January 31, 2023

Record last verified: 2021-12

Locations

CH(4)AU(1)DE(2)