Wednesday, October 04, 2023
Loci Orthopaedics has successfully concluded the enrollment of 15 patients for its clinical feasibility study, titled "Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS)." This study assesses the surgical implantation of the InDx Implant System and its impact on pain relief, grip strength, and overall quality of life among individuals with thumb base joint arthritis.
Dr. Brendan Boland, Executive Chairperson of Loci Orthopaedics, emphasized the significance of addressing thumb base joint arthritis and celebrated the achievement of completing the enrollment phase of the clinical study. He expressed gratitude to the study participants for their invaluable support and indicated that the company looks forward to reporting the study's results next year.
This announcement coincided with the commencement of the annual meeting of the American Society for Surgery of the Hand (ASSH) in Toronto.
Prof. Filip Stockmans, the primary clinical trial investigator and Specialist Orthopaedic Hand Surgeon at KU Leuven, Belgium, underscored the potential of the InDx Implant System to cater to the needs of younger, active patients who require less invasive treatment options. He highlighted that this innovative system is designed to replicate the intricate biomechanics of the thumb base joint with the ultimate goal of restoring its native functionality.
Barry Russell, Chief Executive Officer of Loci Orthopaedics, emphasized the pressing clinical need for evidence-based surgical solutions in addressing thumb base joint arthritis. He expressed optimism that this study will demonstrate the feasibility and positive clinical outcomes associated with the InDx Implant System, which has received De Novo status with the US FDA due to its groundbreaking approach to tackling this condition. Russell also reiterated the company's commitment to collaborating with the FDA to obtain market approval for this significant advancement in Carpometacarpal (CMC) surgery.