Randomized, Prospective Comparison of Two Femoral Reaming Systems
Condition: Femur Fracture
MeSH terms: Femoral Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to compare the quantity of fat that is released into the venous
      system (blood) by reaming the femoral canal during intramedullary nailing of the femur using
      two different reaming systems.
    

Detailed description: 
      Twenty patients who meet criteria for inclusion in this study will be assigned to one of two
      groups by means of a computer-generated random number. Group A will consist of 10 patients
      who undergo reaming with the Synthes reamer-irrigator-aspirator (RIA). Group B will consist
      of 10 patients who undergo conventional reaming with the Zimmer Sentinel reamer.

      The patient will be transported to the operating room and will undergo general anesthesia.
      After correct positioning of the patient on the radiolucent table, baseline data will be
      collected. This data will consist of a transesophageal echocardiogram (TEE) and arterial
      blood gas.

      A standard lateral approach to the proximal femur will be utilized. The starting point will
      be identified using a guide pin and fluoroscopy using standard technique. Though the resident
      may perform the approach, the attending surgeon will perform the case from the opening of the
      canal with a drill through the completion of reaming. A TEE will be recorded from the time
      the initial reamer engages the cortex until it is removed from the bone. A guide wire will be
      passed across the fracture site and its position confirmed by fluoroscopic imaging. The
      femoral canal will be reamed using either a conventional reaming technique or the RIA device.

      For conventional reaming, successive reamers will be used beginning with an 8mm end-cutting
      reamer and increasing by 1.0 mm increments until cortical "chatter" is detected, then reaming
      will proceed at 0.5 mm increments for two passes. This is the standard practice using current
      technology. A Synthes titanium nail of the appropriate length which is 1.0 - 1.5mm less than
      the last reaming will be chosen for implantation. TEE will be monitored during the pass of
      the first reamer and the last.

      For reaming with the RIA, a reamer-irrigator-aspirator of the appropriate size based on
      pre-operative evaluation of the femoral canal size will be used to perform a single pass down
      the femoral canal. A Synthes titanium femoral nail of the appropriate length will be selected
      for implantation. TEE will be recorded during the reaming. An arterial blood gas will be sent
      after positioning of the patient, when the guide wire is passed down the femoral canal and
      after the proximal locking screws are placed.

      Proximal and distal locking screws will be placed in standard fashion. Wound closure and
      post-operative care will be according to standard protocols.

      The TEE will be evaluated in a blinded manner by two anesthesiology attendings certified to
      use and evaluate the TEE. A grading system of 1 through 5 will be used, with 1 representing
      little to no fat emboli and 5 representative of a large number of fat emboli. This data will
      be forwarded to the principal investigator and used to fill the appropriate data sheet.

      Outpatient follow-up will be performed in the usual manner, with sutures/staples being
      removed at approximately 2 weeks, and radiographs being obtained at 6 and 12 weeks as the
      attending physician deems clinically necessary. Follow-up for both limbs of the study will be
      the same as patients not in the study who undergo femoral nailing.
    

Intervention name(s): Synthes Reamer-Irrigator-Aspirator (RIA); Zimmer Sentinel Reamer
Intervention type(s): Device; Device
Intervention description(s): A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram (TEE) will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using the RIA device.; A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram TEE will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using either a conventional reaming technique or the RIA device.
Other intervention name(s): Reamer-Irrigator-Aspirator, Synthes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Synthes Reamer-Irrigator-Aspirator (RIA); Zimmer Sentinal Reamer; Transesophageal Echocardiogram (TEE)