Studies Presented at AOSSM Confirm Significant Benefits of Sonoma's Clavicle Nail Compared to Plating and Slinging
BUFFALO GROVE, Ill., July 25, 2013 /PRNewswire/ -- On July 13, 2013 at the American Orthopedic Society for Sports Medicine (AOSSM) annual meeting, several studies were presented demonstrating the superiority of Sonoma Orthopedic Products, Inc.'s (Sonoma) CRx® collarbone nail compared to alternative treatment options for displaced clavicle fractures.
"Clavicle fractures have historically been treated either by surgically stabilizing the fracture with a metal plate or by keeping the patient in a sling for several months. But these solutions are plagued with high complication and patient dissatisfaction rates," says Rick Epstein, Sonoma's CEO; "For the first time, a treatment is available that provides a great surgical solution with high levels of patient satisfaction."
At the AOSSM meeting, two well-respected surgeons, Dr. Carl Basamania (Seattle, Washington) and Dr. Reggie King (Cape Town, South Africa) both presented studies demonstrating superiority of the CRx® to slings or surgical plating for both transverse and comminuted fractures. Compared to these technologies, CRx® patients exhibited better patient satisfaction scores (Constant and DASH scores). However, the most remarkable finding was a tenfold reduction in the incidence of implant removal for patient dissatisfaction for CRx compared with plates.
Basamania reported on a meta-analysis demonstrating a minimum of 8.42% of 558 plates were removed for patient discomfort from irritation or prominence. For the CRx®, the revision rate was only 0.88%; almost ten-times less in a series of 342 consecutive Sonoma patients across all surgeons. He also cited a 1997 study by J. Hill stating a 30% long-term dissatisfaction rate for patients who were treated with a sling only. In addition, King found almost a 20-minute average reduction in surgical time when using CRx® compared to plating in his series of 40 randomized patients.
Patient dissatisfaction with plating is a common complication. Plates can be felt under the skin and may cause pain. When a plate and accompanying bone screws are removed due to discomfort, multiple holes are left in the collarbone. This makes the bone vulnerable to refracture. This was published recently by the Steadman Philippon Research Institute (SPRI) which found plate removal left a fourth-generation sawbone over two and a half-times weaker than a removed CRx® nail. "Generally, plates are implanted in young, athletic males who wish to resume their normal activities but are withheld from doing so for months due to their surgeons' very rational fears of refracture," says Alex Winber, Sonoma VP of Marketing; "The CRx® is an intramedullary device that drastically reduces patient-requested revisions."
Collarbone fractures have historically been treated differently than other large bones which are routinely repaired with intramedullary rods. In these applications, it is generally accepted that rods are advantageous compared to plating because of earlier rehabilitation and less-invasive insertion which spares muscle and avoids damage to other tissues. However, the collarbone is "S" shaped which makes it difficult to repair with traditional rods due to an inability to match the curved contours. The CRx® nail features patented "flexible-to-rigid" technology that allows it to be navigated along the curved central canal of the collarbone and then turn rigid after it anatomically aligns the fracture.
Several studies are underway which are expected to provide additional support for the CRx® device. Sonoma is looking forward to the results, and is anticipating they will propel this product to even wider acceptance in the orthopedic community.
Founded in 2005, Sonoma is venture-backed and recognized for its proprietary flexible-to-rigid rod technologies for extremity fractures. The technologies allow flexible rods to be navigated through micro incisions into fractured bones without disturbing muscles and nerves like traditional treatments. Once in position, the rods are made rigid to provide comfort with stabilization and healing. The company produces devices for the collarbone, radius and humerus, which are some of the most commonly fractured bones. Additionally, other underserved indications are being evaluated. For more information, visit http://www.sonomaorthopedics.com/.
Sonoma Orthopedic Products, Inc.
Alex Winber, VP of Marketing
SOURCE Sonoma Orthopedic Products, Inc.