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

Not Applicable

Completed

• Conditions: Femoral Fractures
• Interventions: Procedure: Reaming/Irrigating/Aspirating; Procedure: Standard Reaming

• Registration Number: NCT00534326
• Lead Sponsor: Prisma Health-Upstate

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Primary Completion: 2015-12
• Study Completion: 2018-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Reaming/Irrigating/Aspirating	Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing
1	Standard Reaming	Standard Reaming of femoral shaft fracture prior to intramedullary nailing

Primary Outcome Measures

Name	Time	Method
Fracture Healing	3 months, 6 months, 1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
Patient Based Quality of Life	Baseline, 3 months, 6 months, 1 year, 2 years

Trial Locations

Locations (9)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

University of Missouri- Columbia; 🇺🇸 Columbia, Missouri, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Greenville Hospital System Univeristy Medical Center; 🇺🇸 Greenville, South Carolina, United States

University of Tennessee-Chattanooga Unit; 🇺🇸 Chattanooga, Tennessee, United States

Carilion Medical Center; 🇺🇸 Roanoke, Virginia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Palmetto Health; 🇺🇸 Columbia, South Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States