Orthopedics This Week | February 16, 2016 | Page 7

7 ORTHOPEDICS THIS WEEK VOLUME 12, ISSUE 6 | FEBRUARY 16, 2016 patient safety was not compromised. All adverse events were independently reviewed and adjudicated by a Clinical Events Committee (CEC), with their decision binding on the study sponsor. All radiographs were analyzed by an independent core lab (Medical Metrics, Inc.). All patients were re-examined at 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months and, now, 60 months postoperatively. Patients were evaluated for Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), SF-12, back and leg pain (via visual analog scale (VAS)), and neurological assessment at preoperative visit and at all postoperative visits. Radiographic evaluation was performed at all time points. Adverse events and complications were recorded at all visits. duced similar results—but with most measures at most time points, Coflex patients did better than fusion patients. Now, the 5-Year Follow-Up Data At five years: Two tables at the end of this section will provide more details and the study itself is available here http://www.paradigmspine.com/content/abstract-archive. For all patient derived parameters, the researchers found a statistically significant improvement for patients treated with Coflex through the five-year followup period. At five years, more Coflex treated patients reported pain improvement of at least 20mm in VAS leg pain than fusion patients and over 80% at least 15 point improvement in ODI. By all patient derived parameters, the two treatments (Coflex and fusion) pro- • More Coflex patients at all followup time points achieved at least a 15 point improvement in ODI (80% vs 76%) and at least a 20mm VAS leg pain (80.0% vs 77%) and VAS back pain improvement (83.9% vs 75.5%) as compared to the fusion group. • 50% of the Coflex patients and 44% of the fusion patients met the FDA’s clinical success composite endpoint. • The FDA required that the Coflex investigators use a Bayesian statistical comparison between the Coflex and fusion groups. Here’s gSource ® Orthopedic Source for Surgical Instruments gSource advantages gSource is committed to putting the finest instruments into the hands of surgeons and their teams. • Realistic price • German craftsmanship e urc gSo • Orthopedic and spinal focus gSource • Precise U.S. machining gSource • On-time delivery gSource • Verified quality • On-site CAD/engineering support • Large selection and inventory of over 3,500 instrument patterns • Adaptability/flexibility gSource produces instruments used throughout the world by many of the leaders and innovators in orthopedics and spine. • Superior customer service • Full satisfaction guarantee • ISO 13485:2003 Certified AAOS Annual Meeting - Booth 2447 - March 2-4, 2016 Visit www.gSource.com to view our catalog of over 3,500 instruments. gSource instruments are designed to perform with precise surgical function. Whether crafted from German surgical stainless steel, or machined from U.S. surgical stainless steel, they are also conceived to be affordable. It is this combination of quality and realistic pricing that distinguishes the gSource brand. 800.978.1119 www.gSource.com Advertisement ryortho.com | 1-888-749-2153