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

Prisma Health-Upstate

Status: Completed

Conditions: Femoral Fractures

Treatments: Procedure: Standard Reaming; Procedure: Reaming/Irrigating/Aspirating

Study type: Interventional

Funder types: Other

Identifiers

NCT00534326

Ort-07-06-06

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

1

Active Comparator group

Description:

Standard Reaming of femoral shaft fracture prior to intramedullary nailing

Treatment:

Procedure: Standard Reaming

2

Active Comparator group

Description:

Reamer/Irrigator/Aspirating of femoral shaft fracture prior to intramedullary nailing

Treatment:

Procedure: Reaming/Irrigating/Aspirating