NCT00593333

Brief Summary

This project is designed to determine whether or not the trochanteric insertion portal will show any difference when compared with the piriformis fossa portal in terms of pain and strength of the hip abductor muscles, while allowing faster surgical fixation of the femur fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

November 11, 2013

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

5.5 years

First QC Date

December 20, 2007

Results QC Date

September 5, 2013

Last Update Submit

June 1, 2017

Conditions

Femur Fracture

Keywords

Femur FractureIntramedullary NailingTrochanteric NailingPiriformis Starting PortalTrochanteric Insertion Portal

Outcome Measures

Primary Outcomes (1)

  • Healed Femur Fracture

    Time to clinically healed fracture as measured by weeks.

    baseline to healed fracture (weeks)

Study Arms (2)

1, A

ACTIVE COMPARATOR

Standard femoral intramedullary nail that utilizes a piriformis fossa portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur.

Device: Antegrade Intramedullary Nail

2, B

EXPERIMENTAL

Trigen Trochanteric Femoral Nail (Smith \& Nephew, Memphis)using a trochanteric insertion portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur

Device: Trigen Trochanteric Femoral Nail

Interventions

Antegrade Intramedullary NailDEVICE

Use of an antegrade intramedullary nail implanted through the Piriformis fossa of the femur. The use of these nails has yielded a union rate of 97 - 99%, and has clearly become the most commonly utilized implant for femur fractures.

1, A
Trigen Trochanteric Femoral NailDEVICE

Antegrade intramedullary nails developed with a proximal lateral bend that allows implantation through the greater trochanter rather than the piriformis fossa. This start portal is remarkably easier to locate and may be associated with decreased risk of abductor muscle weakness and pain.

Also known as: Trigen Trochanteric Femoral Nail, Smith & Nephew, Inc.
2, B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fracture patterns of the proximal or middle thirds of the femur that will allow antegrade insertion of a femoral nail
  • Adult patient (19 years and older)

You may not qualify if:

  • Nonunions of the femur
  • Pathologic fractures
  • Documented prior femur fractures with surgical stabilization with an antegrade nail
  • Patients who are pregnant, mentally disturbed, or prisoners
  • Inability to comply with protocol
  • Patients or family members who are unable or unwilling to sign study consent
  • Any fracture too proximal or too distal to use an interlocking screw

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Ricci WM, Schwappach J, Tucker M, Coupe K, Brandt A, Sanders R, Leighton R. Trochanteric versus piriformis entry portal for the treatment of femoral shaft fractures. J Orthop Trauma. 2006 Nov-Dec;20(10):663-7. doi: 10.1097/01.bot.0000248472.53154.14.

    PMID: 17106375BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Results Point of Contact

Title
Taylor Vlack, Research Nurse Coordinator
Organization
Department of Surgery/Division of Orthopaedics
tmwebb@uabmc.edu
205-996-6781

Study Officials

  • David A Volgas, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
Principal Investigator

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 15, 2008

Study Start

June 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 5, 2017

Results First Posted

November 11, 2013

Record last verified: 2017-06

Locations

US(1)