NCT03491189

Brief Summary

This study evaluates the rate of cut-out and fixation failures in helical blade fixation versus lag screw fixation for cephalomedullary nailing of peritrochanteric femur fractures.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

March 29, 2018

Last Update Submit

August 30, 2018

Conditions

Pertrochanteric Fracture of Femur, Closed

Outcome Measures

Primary Outcomes (1)

  • Implant cut-out

    Rate of implant cut-out after cephalomedullary nailing of peritrochanteric femur fractures in a randomized prospective study.

    12 months

Study Arms (2)

Lag screw fixation

ACTIVE COMPARATOR

Lag screw fixation

Device: Lag screw fixation

Helical Blade fixation

ACTIVE COMPARATOR

Helical Blade fixation

Device: Helical blade fixation

Interventions

Lag screw fixationDEVICE

surgical fixation

Also known as: Cephalomedullary Hip Screw
Lag screw fixation
Helical blade fixationDEVICE

surgical fixation

Also known as: Cephalomedullary Blade
Helical Blade fixation

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients presenting with low-energy peritrochanteric femur fractures
  • Age 55 years and older
  • Sex: male or female

You may not qualify if:

  • Non English speaking
  • Age \< 55 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Orthopaedics

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 9, 2018

Study Start

April 1, 2018

Primary Completion

June 19, 2018

Study Completion

June 19, 2018

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share