Session III - Hip / Femur

Fri., 10/11/13 Hip/Femur, PAPER #46, 10:15 am OTA 2013

Δ A Prospective Randomized Trial Investigating the Effect of the Reamer-Irrigator-Aspirator (RIA) on the Volume of Embolic Load and Respiratory Functions During Intramedullary Nailing of Femoral Shaft Fractures

Jeremy A. Hall, FRCSC; Michael D. McKee, MD; Milena R. Vicente, RN;
Zachary A. Morison; Niloofar Dehghan; Hans J. Kreder, MD; Brad Petrisor, MD;
Emil H. Schemitsch, MD;
St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

Background/Purpose: Reamed, statically locked intramedullary nailing of femoral shaft fractures is associated with a high rate of clinical success. However, reaming is associated with the generation of embolic debris from the intramedullary canal that can cause serious pulmonary, neurologic, and systemic sequelae, including death. The Reamer-Irrigator-Aspirator (RIA) device has been introduced to minimize the amount of marrow debris from the femoral canal during the reaming process. However, to our knowledge, there are no definitive clinical data to confirm this theoretical advantage of the RIA. Using a randomized clinical trial, we sought to determine if the use of the RIA resulted in a decreased amount of emboli compared to standard reaming.

Methods: We performed a prospective, multicenter, randomized clinical trial comparing standard intramedullary reaming versus reaming with the RIA device for isolated, closed femoral shaft fractures. A random number generator was used to randomize consecutive patients to one of two treatment groups: (1) statically locked reamed intramedullary nailing using standard reamers (SR), or (2) statically locked reamed intramedullary nailing using the RIA device (RIA). In addition to physiologic monitoring, all patients were monitored intraoperatively with a continuous transesophageal echocardiogram (TEE) in order to determine the quantity of embolic debris generated by the procedure. The TEE was divided into preoperative (PREOP), reduction (RED), guidewire passage (GW), reaming (REAM), nail insertion (NAIL), and postoperative (POSTOP) segments. The TEE recordings were analyzed for duration, size, and severity of emboli by 3 blinded independent observers.

Results: 28 patients were enrolled; 6 were excluded due to technical difficulties with the TEE/recording. 22 patients completed the study (SR 11, RIA 11). There were no demographic differences between the two groups (SR male/female 7/4, RIA 8/3, P = 0.879; mean age SR group 39.2 years, RIA group 39.2 years, P = 0.998). The ISS and mechanisms of injury were similar between the two groups. We used a standard, previously validated scoring system for the measurement of emboli from the TEE video recordings. There was a high degree of agreement for the measurements between the three reviewers (intraclass correlation coefficient 0.740, substantial agreement). There was no significant difference in emboli (which escalated beginning with the GW phase) between the two groups during the PREOP, RED, GW, or POSTOP segments. There was a modest reduction in total emboli score during the REAM (SR 5.36 vs RIA 4.06, P <0.05) and NAIL segments (SR 5.15 vs RIA 4.18, P <0.05) in favor of the RIA group. We were unable to correlate this reduction with any improvement in physiologic parameters (mean arterial pressure, end tidal CO2, O2 saturation, pH, paO2, paCO2).

Conclusion: To our knowledge, this is the first clinical study that examines the effect of the RIA device on emboli; it resulted in a modest reduction of embolic debris during the reaming and nail insertion segments of the operative procedure. We were unable to correlate this with any change in physiologic parameters. Further research in this area is warranted to determine if this modest reduction in emboli with the RIA during the REAM and NAIL segments of femoral nailing results in any physiologic improvement and warrants its increased expense.

Alphabetical Disclosure Listing

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant.