Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 20, 2007
March 24, 2014
December 2006
December 2015   (final data collection date for primary outcome measure)
Fracture Healing [ Time Frame: 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Fracture Healing
Complete list of historical versions of study NCT00534326 on ClinicalTrials.gov Archive Site
Patient Based Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Patient Based Quality of Life
Not Provided
Not Provided
 
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Femoral Fractures
  • Procedure: Standard Reaming
    Femoral reaming using standard reaming techniques of multiple reamers
  • Procedure: Reaming/Irrigating/Aspirating
    Reaming using the Reamer/Irrigator/Aspirator
  • Active Comparator: 1
    Standard Reaming
    Intervention: Procedure: Standard Reaming
  • Active Comparator: 2
    Reamer/Irrigator/Aspirator
    Intervention: Procedure: Reaming/Irrigating/Aspirating
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
550
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00534326
Ort-07-06-06
No
Greenville Hospital System University Medical Center
Greenville Hospital System University Medical Center
Not Provided
Principal Investigator: Kyle J Jeray, MD Greenville Hospital System University Medical Center
Greenville Hospital System University Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP