Clinical trial NCT00534326: Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Official title: Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Fractures
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
First posted: 2007-09-24
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fracture Healing
timeFrame: 3 months, 6 months, 1 year, 2 years
Secondary outcomes:
measure: Patient Based Quality of Life
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri- Columbia
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System Univeristy Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: University of Tennessee-Chattanooga Unit
state: Tennessee
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
Study officials:
affiliation: Prisma Health-Upstate
name: Kyle J Jeray, MD
role: PRINCIPAL_INVESTIGATOR
References: