NCT03975868

Brief Summary

Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

5.8 years

First QC Date

June 4, 2019

Last Update Submit

June 4, 2019

Conditions

Proximal Femoral Fracture

Keywords

Cut-outGamma nailLag-screwTip-apex distanceTrochanteric fracture

Outcome Measures

Primary Outcomes (1)

  • Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head

    3 months

Interventions

Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.OTHER

Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 75 years old operated on for extracapsular proximal femoral fracture.

You may qualify if:

  • Patients over 75 years of age
  • Operated on for extracapsular proximal femoral fracture
  • After bodyheight fall

You may not qualify if:

  • Intra-capsular fractures
  • trochantero-diaphyseal fractures
  • subtrochanteric fractures
  • fractures involving pathological bone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Proximal Femoral FracturesHip Fractures

Condition Hierarchy (Ancestors)

Femoral Neck FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 5, 2019

Study Start

July 1, 2009

Primary Completion

March 31, 2015

Study Completion

March 31, 2015

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share