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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT00534326
First received: September 20, 2007
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention
Femoral Fractures
Procedure: Standard Reaming
Procedure: Reaming/Irrigating/Aspirating

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Resource links provided by NLM:


Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Fracture Healing [ Time Frame: 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Based Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: December 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard Reaming
Procedure: Standard Reaming
Femoral reaming using standard reaming techniques of multiple reamers
Active Comparator: 2
Reamer/Irrigator/Aspirator
Procedure: Reaming/Irrigating/Aspirating
Reaming using the Reamer/Irrigator/Aspirator

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534326

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
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 Hospital System University Medical Center
Investigators
Principal Investigator: Kyle J Jeray, MD Greenville Hospital System University Medical Center
  More Information

No publications provided

Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT00534326     History of Changes
Other Study ID Numbers: Ort-07-06-06
Study First Received: September 20, 2007
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014