RANDOMIZED CONTROLLED TRIAL OF THE RECIPROCATING PROCEDURE DEVICE IN DEEP SYRINGE PROCEDURES.

Abstract

Purpose The reciprocating procedure device (RPD) has been demonstrated to be clinically superior to the conventional syringe in deep needle and syringe procedures, including arthrocentesis, aspiration biopsy, and intra-articular injection of hyaluronate and corticosteroid. We hypothesized that this clinical superiority was due to intrinsic design characteristics of the RPD that permitted one-handed operation and enhanced control of the device by the operating physician. Materials and Methods Twenty physicians were tested for their ability to control a syringe and needle during a typical aspiration procedure with the RPD versus the traditional syringe using the validated quantitative needle-based displacement procedure model. Outcomes included unintended forward penetration (loss of control of the needle in the forward direction measured in mm), unintended retraction (loss of control of the needle in the reverse direction), and the ability to generate vacuum. Physicians operated the RPD with one hand and operated the traditional syringe alternatively with one hand and two hands. A nonoperating observer recorded all outcomes and measurements. Results The traditional syringe demonstrated a significant unintended forward penetration of 13.9 ± 2.3 mm (one-handed) and 9.02 ± 3.11 mm (two-handed). The RPD reduced unintended forward penetration to 7.39 ± 1.83 mm (a reduction of 47% and 18% respectively, p Conclusions The RPD with one hand generates vacuum more easily and is better controlled by physicians during typical interventional syringe procedures than the conventional syringe with one or two hands. The RPDs of all sizes are better controlled and superior to conventional syringes for typical interventional syringe procedures, including arthrocentesis and joint injection.