Compassionate use may provide better hip replacement options for patients with spinal fusion and/or spinal pelvic disorders
Boca Raton, FL, March 6, 2025 / OrthospineNews / – HIP Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions that promote the quality of life and quality of care for patients, has announced the Food and Drug Administration (FDA).
“We are extremely encouraged to provide reverse hip replacement systems for at-risk patients,” said Stephen J. Zabinski, medical director of joint replacement surgery and assistant chairman of the surgical department at Shore Medical Center. “I know that, like other research investigators, we are identifying patients who may be candidates for this compassionate use clause. One patient approved by the FDA is scheduled for proceedings at our agency later this month.”
Data supports caring use
The currently available hip system is not very suitable for patients with previous spinal fusion. Christopher G. Salib, MD, ET. Al. In the 2019 Bone & Joint Journal, these patients significantly increase the risk of dislocation due to changes in spinal pelvic mechanics.
Arthur L. Marcani, support for evidence by Maryland. Al. The 2018 Journal of Arthroplasty shows that lumbar fusion patients had an 80% increase in dislocation at 6 months, 71% in one year and 60% in two years, compared to patients without lumbar fusion. 2
“We’re committed to providing a range of services to our customers,” said George Diamantoni, CEO of HIP Innovation Technology. “The data collected from these cases could help expand the existing literature and provide potential new options for patients with spinal fusion and spinal pelvic disorders. Our hope is to provide these patients with new options that can lower the risk of dislocations and improvement outcomes with reversed HRS.”
Regarding the reverse HR
Inverse HRS is a metal-on-polyethylene inverse geometric hip prosthesis designed to improve stability over extended ranges and reduce the risk of dislocation. Like most traditional systems, the inverse HRS consists of femoral stalks, acetic acid cups, and cobalt chrome balls articulating within the polyethylene liner. Unlike existing total hip replacement systems, the ball is placed in a truunion inside the acetic acid cup instead of the femoral stem, and the polyethylene liner is attached to the femoral cup, which adheres to the femoral shaft, in contrast to the polyethylene liner attached to the acetic acid cup. The difference in this technique does not change the center of rotation of the inverse HR and remains similar to normal physiological hip joints and well-positioned traditional hip arthroplasty. Advanced inverted HRS implants are designed to provide a wider range of motion on all planes, increase hip stability and reduce the risk of dislocation. Importantly, inverse HRS also provides variability in component placement, including higher adeduction angles and inversion of acetabular cups. The femoral cup defines the area around the acetabulum ball and overlaps with the acetabulum cup when the hip joint undergoes flexion extension, adduction adaptation, and internal outlet rotation. This tolerant design may compensate for suboptimal component positioning that may offer benefits such as extended range of motion, hip stability, and reduced chances of collision. The reverse HRS is designed to remove the relationship between component placement, wear and stability. This unique implant design of inverted HRS provides optimal surface area contact between the acetabular ball and femoral cup, potentially eliminating edge loading. Removal of edge loads can provide benefits including reduced high contact stress, reduced implant wear, and even wear, minimizing related concerns related to wear production and osteolysis.
HIP Innovation Technology, LLC
Headquartered in Boca Raton, Florida, HIP Innovation Technology was founded in 2011 to provide market-leading orthopedic device solutions that enhance the quality of life and care of patients. Working with health professionals around the world, our goal is to identify unmet clinical needs, design, manufacture and ultimately sell innovative orthopedic reconstruction and related surgical product solutions.
For more information, please visit www.hipinnovationtechnology.com.
contact:
John F. Cooten
JFK Communications, Inc.
(609) 456-0822
jfkouten@jfkhealth.com
Source: HIP Innovation Technology, LLC
1. Aggregate involvement J. LUMINUM fusion increases the risk of dislocation in primary hip arthroplasty. February 2019; 101-B(2): 198-206. doi: 10.1302/0301-620x.101b2.bjj-2018-0754.r1.
2. J-arthroplasty. Previous total hip replacement in patients with lumbar fusion surgery: Are there more dislocations and revisions? April 2018; 33(4): 1189-1193. doi: 10.1016/j.arth.2017.10.041. EPUB 2017 October 31st
