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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fractures
• Intervention / Treatment: Procedure: Standard Reaming; Procedure: Reaming/Irrigating/Aspirating

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fracture Healing	3 months, 6 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Based Quality of Life	Baseline, 3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: University of Missouri-Columbia
• Investigators: Principal Investigator: Kyle J Jeray, MD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: September 20, 2007
• First Submitted That Met QC Criteria: September 20, 2007
• First Posted (Estimate): September 24, 2007

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: Ort-07-06-06