Orthopaedic Trauma Fractures and Non-unions Clinical Trial
Official title:
The Use of the Reamer-Irrigator-Aspirator (RIA) to Harvest Bone Graft for Treatment of Non-unions and Fractures
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment