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KeriMedical (a Medartis Group company) has officially launched the first clinical study of the TOUCHi CMC 1 Prosthesis in a U.S. patient population (NCT #7405983). This is the first in a 163-patient post-approval study commitment to FDA. Patients will be followed for a minimum of two years to observe the rate of pain reduction and functional improvement.
TOUCH CMC 1 Prosthesis is intended for first carpometacarpal (CMC) primary total joint arthroplasty in patients with symptomatic Eaton-Littler Stage II or III osteoarthritis. FDA approval (PMA 240020) of this cementless, dual-mobility total CMC prosthesis was supported by a body of clinical evidence established over a decade of market presence in Europe.
“We are excited to help launch the first US study that will provide insight into the benefits of total joint replacement for patients suffering from debilitating thumb arthritis. Our patients deserve a better option that may provide quicker recovery and better strength than traditional surgery. This study has the potential to pave the way for a paradigm shift in how US surgeons treat thumb arthritis – just as hip replacement surgery did decades ago.” – F. Thomas D. Kaplan M.D., fellowship director at Indiana Hand to Shoulder Center
“This first patient inclusion marks an important milestone in our post approval study, conducted in accordance with FDA requirements. Trough the collaboration with MCRA, an IQVIA business, and medical centers experienced in clinical studies, KeriMedical is committed to ensuring the quality of this study. We hope this will be a first step towards scientific research on the TOUCH CMC 1 Prosthesis in the United States.” – Déborah Caux, Clinical Affairs Manager, KeriMedical SA, a Medartis Group company
“We thank the study team and forthcoming patients for their contribution to US clinical evidence related to first carpometacarpal total joint arthroplasty with TOUCH CMC 1 Prosthesis,” stated Charles Florek Ph.D., Director of Clinical Research for Medartis Inc.
TOUCH CMC 1 Prosthesis is commercially available in the United States, PMA 240020.
KeriMedical (a Medartis Group company) has officially launched the first clinical study of the TOUCHi CMC 1 Prosthesis in a U.S. patient population (NCT #7405983). This is the first in a 163-patient post-approval study commitment to FDA. Patients will be followed for a minimum of two years to observe the rate of pain reduction and functional...
KeriMedical (a Medartis Group company) has officially launched the first clinical study of the TOUCHi CMC 1 Prosthesis in a U.S. patient population (NCT #7405983). This is the first in a 163-patient post-approval study commitment to FDA. Patients will be followed for a minimum of two years to observe the rate of pain reduction and functional improvement.
TOUCH CMC 1 Prosthesis is intended for first carpometacarpal (CMC) primary total joint arthroplasty in patients with symptomatic Eaton-Littler Stage II or III osteoarthritis. FDA approval (PMA 240020) of this cementless, dual-mobility total CMC prosthesis was supported by a body of clinical evidence established over a decade of market presence in Europe.
“We are excited to help launch the first US study that will provide insight into the benefits of total joint replacement for patients suffering from debilitating thumb arthritis. Our patients deserve a better option that may provide quicker recovery and better strength than traditional surgery. This study has the potential to pave the way for a paradigm shift in how US surgeons treat thumb arthritis – just as hip replacement surgery did decades ago.” – F. Thomas D. Kaplan M.D., fellowship director at Indiana Hand to Shoulder Center
“This first patient inclusion marks an important milestone in our post approval study, conducted in accordance with FDA requirements. Trough the collaboration with MCRA, an IQVIA business, and medical centers experienced in clinical studies, KeriMedical is committed to ensuring the quality of this study. We hope this will be a first step towards scientific research on the TOUCH CMC 1 Prosthesis in the United States.” – Déborah Caux, Clinical Affairs Manager, KeriMedical SA, a Medartis Group company
“We thank the study team and forthcoming patients for their contribution to US clinical evidence related to first carpometacarpal total joint arthroplasty with TOUCH CMC 1 Prosthesis,” stated Charles Florek Ph.D., Director of Clinical Research for Medartis Inc.
TOUCH CMC 1 Prosthesis is commercially available in the United States, PMA 240020.
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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.
