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Loci Orthopaedics successfully completed enrollment of a 15-patient clinical feasibility study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS) study will examine surgical implantation of the device and improvements in pain, grip and quality of life for those affected by thumb base joint arthritis.
Primary Clinical Trial Investigator Prof. Filip Stockmans, Specialist Orthopaedic Hand Surgeon, KU Leuven, Belgium, commented, “There is a cohort of younger active patients that currently are not optimally served by the treatment options available to them, particularly in the US. The InDx Implant System may provide an additional treatment alternative for a large cohort, with the potential to treat these patients in a less invasive fashion than what is currently available. The InDx Implant System is the first implant to mimic the complex biomechanics of the thumb base joint, with the goal of restoring native biomechanics.”
Barry Russell, Chief Executive Officer of Loci Orthopaedics, added, “There is a significant unmet clinical need to provide an evidence-based surgical solution for this condition. This study will help demonstrate the feasibility of this implant use as well as the positive clinical outcomes that an evidence-based solution can bring. The novelty of this solution is reflected in its De Novo status with the US FDA, as it is not like any prior implant developed to date. We look forward to continuing our work with the FDA to gain market approval for this important advancement in CMC surgery.”
Earlier this year, the company was granted a new U.S. patent for the bespoke implantation set for the InDx CMC (carpometacarpal) implant system.
Source: Loci Orthopaedics
Loci Orthopaedics successfully completed enrollment of a 15-patient clinical feasibility study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS) study will examine surgical implantation of the device and improvements in pain, grip and quality of life for those affected by thumb base joint arthritis.
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Loci Orthopaedics successfully completed enrollment of a 15-patient clinical feasibility study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS) study will examine surgical implantation of the device and improvements in pain, grip and quality of life for those affected by thumb base joint arthritis.
Primary Clinical Trial Investigator Prof. Filip Stockmans, Specialist Orthopaedic Hand Surgeon, KU Leuven, Belgium, commented, “There is a cohort of younger active patients that currently are not optimally served by the treatment options available to them, particularly in the US. The InDx Implant System may provide an additional treatment alternative for a large cohort, with the potential to treat these patients in a less invasive fashion than what is currently available. The InDx Implant System is the first implant to mimic the complex biomechanics of the thumb base joint, with the goal of restoring native biomechanics.”
Barry Russell, Chief Executive Officer of Loci Orthopaedics, added, “There is a significant unmet clinical need to provide an evidence-based surgical solution for this condition. This study will help demonstrate the feasibility of this implant use as well as the positive clinical outcomes that an evidence-based solution can bring. The novelty of this solution is reflected in its De Novo status with the US FDA, as it is not like any prior implant developed to date. We look forward to continuing our work with the FDA to gain market approval for this important advancement in CMC surgery.”
Earlier this year, the company was granted a new U.S. patent for the bespoke implantation set for the InDx CMC (carpometacarpal) implant system.
Source: Loci Orthopaedics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
