Abstract
Problem
Total hip replacement (THA) is among the most common and highest total spend elective operations in the United States. However, up to 7% of patients have 90-day complications after surgery, most frequently joint dislocation that is related to poor acetabular component positioning. These complications lead to patient morbidity and mortality, as well as significant cost to the health system. As such, surgeons and hospitals value navigation technology, but existing solutions including robotics and optical navigation are costly, time-consuming, and complex to learn, resulting in limited uptake globally.
Solution
Augmented reality represents a navigation solution that is rapid, accurate, intuitive, easy to learn, and does not require large and costly equipment in the operating room. In addition to providing cutting edge technology to specialty orthopedic centers, augmented reality is a very attractive solution for lower volume and smaller operative settings such as ambulatory surgery centers that cannot justify purchases of large capital equipment navigation systems.
Product
HipInsight™ is an augmented reality solution for navigation of the acetabular component in THA. HipInsight is a navigation solution that includes preoperative, cloud based surgical planning based on patient imaging and surgeon preference of implants as well as intraoperative guidance for placement of the acetabular component. Once the patient specific surgical plan is generated on the cloud-based planning system, holograms showing the optimal planned position of the acetabular component are exported in holographic format to a Microsoft HoloLens 2™, which the surgeon wears during placement of the acetabular component in total hip arthroplasty. The pelvis is registered using the HipXpert™ mechanical registration device, which takes 2–3 minutes to dock in the operating room. The surgeon then is able to view the patient's anatomy and optimal placement of the acetabular component under the skin in augmented reality. The surgeon then aligns the real cup impactor with the augmented reality projection of the cup impactor resulting in precise placement of the cup.
Timescales
HipInsight was FDA cleared on January 28, 2021 for intraoperative use for placement of the acetabular component in total hip arthroplasty. The first case was performed in February 2021, and the product was launched to a select group of orthopedic surgeons in March 2021.
Funding
HipInsight has been self-funded to date, and is beginning to engage in discussions to raise capital for a rapidly scaling commercial launch.
