An Ireland-based orthopedics firm has announced that they have concluded enrollment for a feasibility study surrounding the surgical implantation of artificial thumb joints.
Galway-centered Loci Orthopedics has recruited 15 patients for a clinical feasibility study of its InDx Implant System, an implant intended to restore joint mobility to those suffering from thumb base joint arthritis.
Thumb arthritis is common with ageing and occurs when cartilage wears away from the ends of the bones that form the joint at the base of the thumb. The InDx implant is intended to mimic the biomechanics of the thumb base joint, with the goal of restoring full movement in the joint.
Primary clinical trial investigator, Filip Stockmans, said: “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.”
Named, The Thumb Hemi-Arthroplasty with Natural Kinematics (THANKS) study, the research is aimed at examining the surgical implantation of the device, as well as improvements in pain, grip, and quality of life for those affected.
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The company announced the completion of the clinical trial enrolment just prior to the start of the annual meeting of the American Society for Surgery of the Hand in Toronto.
The company argues that the InDx implant is the only implant that can fully mimic the natural and complex motions of the thumb joint.
It also claims that the device is easier to insert and less invasive than any currently available surgical treatment option for this condition.
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”.