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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00534326
Recruitment Status : Active, not recruiting
First Posted : September 24, 2007
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Greenville Health System

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.

Condition or disease Intervention/treatment
Femoral Fractures Procedure: Standard Reaming Procedure: Reaming/Irrigating/Aspirating

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Study Start Date : December 2006
Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Standard Reaming of femoral shaft fracture prior to intramedullary nailing
Procedure: Standard Reaming
Femoral reaming using standard reaming techniques of multiple reamers
Active Comparator: 2
Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing
Procedure: Reaming/Irrigating/Aspirating
Reaming using the Reamer/Irrigator/Aspirating

Primary Outcome Measures :
  1. Fracture Healing [ Time Frame: 3 months, 6 months, 1 year, 2 years ]

Secondary Outcome Measures :
  1. Patient Based Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534326

United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Missouri
University of Missouri- Columbia
Columbia, Missouri, United States, 65212
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Palmetto Health
Columbia, South Carolina, United States, 29203
Greenville Hospital System Univeristy Medical Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
University of Tennessee-Chattanooga Unit
Chattanooga, Tennessee, United States, 37403
United States, Virginia
Carilion Medical Center
Roanoke, Virginia, United States, 24033
Sponsors and Collaborators
Greenville Health System
Principal Investigator: Kyle J Jeray, MD Greenville Health System

Responsible Party: Greenville Health System
ClinicalTrials.gov Identifier: NCT00534326     History of Changes
Other Study ID Numbers: Ort-07-06-06
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries