First Release Mar 1

ABSTRACT. Objective. To evaluate physician control of needle and syringe during aspiration-injection syringe procedures by comparing the new reciprocating procedure syringe to a traditional conventional syringe. Methods. Twenty-six physicians were tested for their individual ability to control the reciprocating and conventional syringes in typical aspiration-injection procedures using a novel quantitative needle-based displacement procedure model. Subsequently, the physicians performed 48 clinical aspiration-injection (arthrocentesis) procedures on 32 subjects randomized to the reciprocating or conventional syringes. Clinical outcomes included procedure time, patient pain, and operator satisfaction. Multivariate modeling methods were used to determine the experimental variables in the syringe control model most predictive of clinical outcome measures. Results. In the model system, the reciprocating syringe significantly improved physician control of the syringe and needle, with a 66% reduction in unintended forward penetration (p < 0.001) and a 68% reduction in unintended retraction (p < 0.001). In clinical arthrocentesis, improvements were also noted: 30% reduction in procedure time (p < 0.03), 57% reduction in patient pain (p < 0.001), and a 79% increase in physician satisfaction (p < 0.001). The variables in the experimental system -unintended forward penetration, unintended retraction, and operator satisfaction -independently predicted the outcomes of procedure time, patient pain, and physician satisfaction in the clinical study (p ≤ 0.001). Conclusion. The reciprocating syringe reduces procedure time and patient pain and improves operator satisfaction with the procedure syringe. The reciprocating syringe improves physician performance in both the validated quantitative needle-based displacement model and in real aspiration-injection syringe procedures, including arthrocentesis

The highly accurate anteriolateral portal for injecting the knee

<p>Abstract</p> <p>Background</p> <p>The extended knee lateral midpatellar portal for intraarticular injection of the knee is accurate but is not practical for all patients. We hypothesized that a modified anteriolateral portal where the synovial membrane of the medial femoral condyle is the target would be highly accurate and effective for intraarticular injection of the knee.</p> <p>Methods</p> <p>83 subjects with non-effusive osteoarthritis of the knee were randomized to intraarticular injection using the modified anteriolateral bent knee versus the standard lateral midpatellar portal. After hydrodissection of the synovial membrane with lidocaine using a mechanical syringe (reciprocating procedure device), 80 mg of triamcinolone acetonide were injected into the knee with a 2.0-in (5.1-cm) 21-gauge needle. Baseline pain, procedural pain, and pain at outcome (2 weeks and 6 months) were determined with the 10 cm Visual Analogue Pain Score (VAS). The accuracy of needle placement was determined by sonographic imaging.</p> <p>Results</p> <p>The lateral midpatellar and anteriolateral portals resulted in equivalent clinical outcomes including procedural pain (VAS midpatellar: 4.6 ± 3.1 cm; anteriolateral: 4.8 ± 3.2 cm; p = 0.77), pain at outcome (VAS midpatellar: 2.6 ± 2.8 cm; anteriolateral: 1.7 ± 2.3 cm; p = 0.11), responders (midpatellar: 45%; anteriolateral: 56%; p = 0.33), duration of therapeutic effect (midpatellar: 3.9 ± 2.4 months; anteriolateral: 4.1 ± 2.2 months; p = 0.69), and time to next procedure (midpatellar: 7.3 ± 3.3 months; anteriolateral: 7.7 ± 3.7 months; p = 0.71). The anteriolateral portal was 97% accurate by real-time ultrasound imaging.</p> <p>Conclusion</p> <p>The modified anteriolateral bent knee portal is an effective, accurate, and equivalent alternative to the standard lateral midpatellar portal for intraarticular injection of the knee.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00651625">NCT00651625</a></p