TOUCH® CMC 1 New Enrollment US Study

Официальное название

Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study

Обзор

The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.

Подробное описание

TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.

Вмешательства

• Устройство TOUCH® CMC 1 Prosthesis
  The TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components: 1. TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical 2. TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck 3. TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of pla

Первичные конечные точки

• Clinical Composite Success [Срок оценки: 24 Months/2 Years]

Критерии участия

Критерии включения

• Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
• Adult (≥ 22 years of age) at the time of enrollment
• Willing and able to sign the study Informed Consent

Критерии исключения

• Acute or chronic infections, local or systemic
• Muscular, neurological, or vascular severe deficiency affecting the joint
• Inadequate bone quality or quantity preventing the implant fixation
• Bones dimensions incompatible with implant sizes
• Patients who are allergic to the product's materials
• Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
• Skeletally immature (i.e., pediatric population, <22 years of age)
• Pregnant or nursing women
• Patients with contraindications to surgery in general
• Patients with an intellectual disability who cannot follow the instructions of their surgeon.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• University of Colorado, Anschutz School of Medicine — Aurora
• Indiana Hand to Shoulder Center — Indianapolis
• Duke University Medical Center, Department of Orthopaedic Surgery — Morrisville
• University of Texas Health San Antonio, Department of Orthopaedics — San Antonio

Идентификаторы

NCT: NCT07405983 · TOUCH® CMC 1 New Enrollment US

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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