NCT00534326

Brief Summary

Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

9 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

Study Start

First participant enrolled

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

9 years

First QC Date

September 20, 2007

Last Update Submit

March 6, 2020

Conditions

Femoral Fractures

Outcome Measures

Primary Outcomes (1)

  • Fracture Healing

    3 months, 6 months, 1 year, 2 years

Secondary Outcomes (1)

  • Patient Based Quality of Life

    Baseline, 3 months, 6 months, 1 year, 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Standard Reaming of femoral shaft fracture prior to intramedullary nailing

Procedure: Standard Reaming

2

ACTIVE COMPARATOR

Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing

Procedure: Reaming/Irrigating/Aspirating

Interventions

Standard ReamingPROCEDURE

Femoral reaming using standard reaming techniques of multiple reamers

1
Reaming/Irrigating/AspiratingPROCEDURE

Reaming using the Reamer/Irrigator/Aspirating

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women between the ages of 18 years and 85 years;
  • Acute fractures of the femoral shaft

You may not qualify if:

  • Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
  • Pathological fractures;
  • Open fractures;
  • Patients with additional injuries to the ipsilateral femur;
  • Surgical delay of greater than 7 days from the time of injury;
  • Retained hardware in the affected limb;
  • Previous infection in fractured limb;
  • Likely problems in the judgment of the investigators with maintaining follow-up;
  • Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
  • Hopeless diagnosis;
  • Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
  • Fractures requiring cephalomedullary nails

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Missouri- Columbia

Columbia, Missouri, 65212, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Palmetto Health

Columbia, South Carolina, 29203, United States

Location

Greenville Hospital System Univeristy Medical Center

Greenville, South Carolina, 29605, United States

Location

University of Tennessee-Chattanooga Unit

Chattanooga, Tennessee, 37403, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24033, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Kyle J Jeray, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2015

Study Completion

December 30, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(9)