In the US alone, more than 100,000 patients receive shoulder replacement surgery each year, and the demand for the procedure is growing nearly 10 percent every year. Despite increasing demand, driven by expansion of the patient population and higher rates of activity, today's shoulder replacement technologies continue to fall short of surgeon and patient expectations. Some patient populations are experiencing implant loosening rates as high as 20 percent at five years, and revision rates as high as 50 percent at 10 years, which drives patient dissatisfaction and higher health care costs.
Published results in the Journal of Shoulder and Elbow Surgery show improved implant stability of the Shoulder Innovations inset glenoid, demonstrating an 87 percent reduction in implant micro-motion as compared to conventional glenoid design. Furthermore, the Shoulder Innovations System simplifies shoulder replacement technology in order to improve patient outcomes.
"With the existing shoulder replacement technologies available, deficiency of the bone limits the size and options of replacement devices. This results in unreliable fixation of the glenoid implant, further damaging a patient's bone structure, which causes glenoid failure and subsequent revision surgery," said Stephen Gunther, MD, clinical lead of the Shoulder Innovations team. "Our published results show Shoulder Innovations' new inset glenoid solution provides greater post-surgical implant stability, addressing the leading cause of revision surgery."
Led by Dr. Gunther, the Shoulder Innovations clinical team designed a revolutionary surgical technique to address these issues. By countersinking the glenoid implant into the scapula, glenoid stability is enhanced providing a solution targeted directly at the leading cause of implant failure. Furthermore, the team has leveraged the elegant simplicity of the technology to create the simplest possible surgical approach, eliminating operative steps, reducing risk, and thereby delivering overall lower cost and operative times.
"We maximized the potential benefits of the inset technology by working with world class surgeons to create a simple, yet robust shoulder replacement system. The inset glenoid surgery requires fewer steps and allows reduced exposure to the glenoid vault," said Matt Ahearn, president and COO of Shoulder Innovations. "All instrumentation of the Shoulder Innovations' glenoid and humeral system is delivered in one case, which means less storage, handling, cleaning, and sterilization, resulting in fewer costs, while increasing back table efficiency."
Additional results published in the Journal of Shoulder and Elbow Surgery show that near-term results of patients treated with severe glenoid bone loss, with minimum of three, and an average of 4.3 year follow-up, have found documented excellent radiographic and functional results using the inset glenoid implant. Separate studies showed a statistically significant increase in range of motion, reduction in pain and high patient satisfaction.
The inset glenoid design offers a number of key advantages to the current on-lay designs. Since loosening of the glenoid component has been a continued reason for shoulder replacement failure, this new inset design offers a strategic advantage over classic glenoid replacement implants. The strong, circumferential, cortical support of the implant around the perimeter shields the implant from rocking horse loosening forces during daily shoulder motion activities. The flat back design, pegs, and cement channels also potentiate the increased fixation strength that decreases the risk of implant loosening.