NCT03493893

Brief Summary

The aim of this study was to investigate the clinical effects of design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2006

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

10 years

First QC Date

April 10, 2017

Last Update Submit

February 26, 2019

Conditions

Fractured Neck of Femur

Outcome Measures

Primary Outcomes (1)

  • Reoperation

    Taken back to the operating room for reoperation

    12 months

Secondary Outcomes (1)

  • Failure

    12 months

Study Arms (3)

Affixus

To compare Affixus to PFNA and TFNA

Device: Intermedullary nail

PFNA

To compare PFNA to Affixus and TFNA

Device: Intermedullary nail

TFNA

To compare TFNA toPFNA and Affixus

Device: Intermedullary nail

Interventions

Intermedullary nailDEVICE

investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

Also known as: Affixus, PFNA, TFNA
AffixusPFNATFNA

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fractured neck of femur

You may not qualify if:

  • NOT fractured neck of femur

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Cameron Cooke

    Princess Alexandra Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research coordinator

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 11, 2018

Study Start

September 1, 2006

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share