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

Femoral Fractures Clinical Trial

— STAFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534326
• Other study ID #: Ort-07-06-06
• Status: Completed
• Phase: N/A
• Start date: December 2006
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2020
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 30, 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

Procedure:
• Standard Reaming
Femoral reaming using standard reaming techniques of multiple reamers
• Reaming/Irrigating/Aspirating
Reaming using the Reamer/Irrigator/Aspirating

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Tennessee-Chattanooga Unit	Chattanooga	Tennessee
United States	Palmetto Health	Columbia	South Carolina
United States	University of Missouri- Columbia	Columbia	Missouri
United States	Duke University Medical Center	Durham	North Carolina
United States	Greenville Hospital System Univeristy Medical Center	Greenville	South Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Carilion Medical Center	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture Healing		3 months, 6 months, 1 year, 2 years
Secondary	Patient Based Quality of Life		Baseline, 3 months, 6 months, 1 year, 2 years