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Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures (STAFF)

Primary Purpose

Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Reaming
Reaming/Irrigating/Aspirating
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fractures

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Indiana University
  • Lahey Clinic
  • University of Missouri- Columbia
  • Carolinas Medical Center
  • Duke University Medical Center
  • Palmetto Health
  • Greenville Hospital System Univeristy Medical Center
  • University of Tennessee-Chattanooga Unit
  • Carilion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Standard Reaming of femoral shaft fracture prior to intramedullary nailing

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

Outcomes

Primary Outcome Measures

Fracture Healing

Secondary Outcome Measures

Patient Based Quality of Life

Full Information

First Posted
September 20, 2007
Last Updated
March 6, 2020
Sponsor
Prisma Health-Upstate
Collaborators
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00534326
Brief Title
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Acronym
STAFF
Official Title
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard Reaming of femoral shaft fracture prior to intramedullary nailing
Arm Title
2
Arm Type
Active Comparator
Arm Description
Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing
Intervention Type
Procedure
Intervention Name(s)
Standard Reaming
Intervention Description
Femoral reaming using standard reaming techniques of multiple reamers
Intervention Type
Procedure
Intervention Name(s)
Reaming/Irrigating/Aspirating
Intervention Description
Reaming using the Reamer/Irrigator/Aspirating
Primary Outcome Measure Information:
Title
Fracture Healing
Time Frame
3 months, 6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Patient Based Quality of Life
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women between the ages of 18 years and 85 years; Acute fractures of the femoral shaft Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle J Jeray, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Missouri- Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Palmetto Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Hospital System Univeristy Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Tennessee-Chattanooga Unit
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

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