The Use of RIA to Harvest Bone Graft for Treatment of Non-unions and Fractures
Condition: Orthopaedic Trauma Fractures and Non-unions
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      This study is to determine the composition of bone graft harvested using the RIA system in 16
      orthopaedic trauma patients between age 19 and 65 who have sustained a fracture or non-union
      requiring bone grafting. The patients will be followed to assess clinical outcomes and
      associated pain.
    

Detailed description: 
      Early clinical use has suggested that bone graft obtained from the human femur using the RIA
      system is available in large quantities, may be associated with less pain when compared to
      conventional methods of autograft harvest, and may provide bioactive substances in addition
      to bone that aid in the healing process.

      All patients enrolling in this study will be scheduled for bone grafting of their fracture or
      nonunion using the RIA system, irregardless of their participation in the study. There is
      pain associated with the harvest of the bone, but it will be the same whether the patient is
      enrolled in the study or not.

      A total of sixteen patients will be enrolled in this study, eight will have large (2.8 - 5.6
      mm) Beta-Tricalcium Phosphate (ChronOS) granules in the second filter, eight will have medium
      (1.4 - 2.8 mm) Beta-Tricalcium Phosphate (ChronOS)granules. All patients will be enrolled
      after obtaining informed consent. In order to be eligible for the study, the patients must
      already be scheduled for bone grafting of a fracture or nonunion with harvest of autologous
      graft material from their femur using the RIA system. The reaming procedure will be conducted
      using the trochanteric entry portal through the tip of the greater trochanter. The reamer
      size will be determined using fluoroscopy to measure the medullary canal at the isthmus of
      the femur. All bone graft harvest will be obtained using a single pass reaming over a guide
      wire placed centrally in the distal femur. Two 750 micrometer filters will be placed in
      series at the suction end of the RIA. The first filter will collect the bone, and the second
      filter will be filled with Beta-Tricalcium Phosphate. Three samples (< 1 cc) of the bone will
      be collected from the first filter. The first sample will be from the top of the filter, the
      second sample will be obtained halfway down the filter, and the final sample will be obtained
      from the bottom of the filter. Similarly, three samples of Beta-Tricalcium Phosphate will be
      obtained from the second filter. Each of these samples will also be less than 1 cc of
      material. The first sample will be from the top layer, the second sample will be from the
      middle of the Beta-Tricalcium Phosphate layer, and the final sample will be from the bottom
      of the filter. The middle of each filter layer will be determined by measuring the filter
      sample with a ruler and dividing by two. Each of these samples will be stored in dry ice and
      transported to the Department of Surgery laboratories run by Dr. Irshad Chaudry for
      processing as described below. We will also obtain a single sample of the fluid effluent that
      is normally discarded as part of the procedure. That sample will be analyzed for the same
      proteins and factors described below.

      All patients will undergo a needle biopsy of their ipsilateral iliac crest while under
      general anesthesia for their surgical procedure. The bone biopsy will be taken through the
      surgical incision used for placing the reamer irrigator aspirator in most cases. If a patient
      requires only a small incision for placing the reamer, which precludes needle biopsy through
      the surgical incision, then the needle biopsy will occur through a small (< 1 cm) incision
      directly over the iliac crest. The iliac crest biopsy will also be immediately placed on dry
      ice and transported to the Department of Surgery laboratories of Dr. Chaudry for evaluation.
      After the samples have been obtained, the scheduled surgical procedure will be completed.
    

Intervention name(s): Reamer-Irrigator-Aspirator (RIA)
Intervention type(s): Device
Intervention description(s): Patients must already be scheduled for bone grafting of a fracture or nonunion with harvest of autologous graft material from their femur using the RIA system. The reaming procedure will be conducted using the trochanteric entry portal through the tip of the greater trochanter.
Other intervention name(s): Reamer-Irrigator-Aspirator (RIA), Synthes, Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orthopaedic Trauma Fractures; Orthopaedic Trauma Non-unions; Reamer-Irrigator-Aspirator (RIA); Bone Graft