Меню
Идёт набор NCT05719935

The KinematX Midcarpal Total Wrist Arthroplasty Registry

— Наблюдательное Scapholunate Advanced Collapse (SLAC) Scapholunate Crystalline Advanced Collapse (SCAC) Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC) Carpal Tunnel Syndrome (CTS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: KinematX total wrist arthroplasty system.
Кому может быть актуально
Состояния в реестре: Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC), Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC), Carpal Tunnel Syndrome (CTS). Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes

Обзор

The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. The main questions it aims to answer are: * What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery? Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.

Вмешательства

  • Устройство KinematX total wrist arthroplasty system
    The KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint.

Первичные конечные точки

  • Range of Motion (as assessed by physician) [Срок оценки: Up to 10 years]
Вторичные конечные точки (8)
  • PROMIS Upper Extremity Physical Function 7a [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • PROMIS Pain Interference 8a [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • PROMIS Global 10 [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Patient-Rated Wrist Evaluation Score (PRWE) [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Hospital for Special Surgery Wrist Surgery Expectations Survey [Срок оценки: Pre-operative and yearly up to 10 years post-surgery]
  • Percentage of patients experiencing post-operative complications [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Percentage of patients requiring revision surgery for their implant (with or without implant replacement) [Срок оценки: 3 months, 6 months, yearly up to 10 years post-surgery]
  • Grip and pinch strength (as assessed by physician) [Срок оценки: 3months, 6 months, yearly up to 10 years post-surgery]

Критерии участия

Критерии включения

  • one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:
  • osteoarthritis or post-traumatic arthritis
  • scapholunate advanced collapse (SLAC/SNAC wrist),
  • inflammatory arthritis (rheumatoid, psoriatic, other),
  • crystalline advanced collapse (SCAC),
  • STT advanced collapse (STTAC),
  • ulnar translocation,
  • Kienbӧck disease,
  • radial malunion

Критерии исключения

  • <18 years of age
  • >85 years of age
  • Prisoners
  • Children
  • Pregnant women
  • Contraindications to receiving the KinematX:
  • Local, distant or systematic acute or chronic soft tissue or bony infection
  • Physiologically or psychologically compromised patient
  • Active wrist synovitis or severe carpal bone erosion
  • Suspected or documented metal allergy or intolerance
  • Insufficient extensor tendons
  • Inadequate skin, bone, neural or vascular status
  • Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology
  • Sepsis
  • Osteomyelitis
  • Uncontrolled/untreated osteoporosis or metabolic bone disease
  • Metabolic or endocrinologic bone disorders
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

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
  • Loma Linda University — Loma Linda
  • Florida Orthopaedic Institute — Tampa
  • Franciscan Health — Indianapolis
  • Hospital for Special Surgery — New York

Идентификаторы

NCT: NCT05719935 · 112020-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗