Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

Официальное название

(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)

Обзор

Problem: Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee. Hypothesis: A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting. Objectives : * Demonstrating the capacity of the system to precisely measure 3D knee kinematics * Quantifying the reproducibility of the kinematic measurements * Measuring the impact of knee surgical procedures on knee kinematics * Assessing the correlations between measured articular kinematics and clinical results after knee surgery * Integrating the novel measuring system to the surgical flow of three knee surgical procedures * Quantifying the precision and reproducibility of the surgical actions guided by the system * Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

Подробное описание

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Вмешательства

• Устройство Repeated Measurements of Knee Alignment and Kinematics
  Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
• Устройство Computer Guidance of Surgical Actions
  Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

Первичные конечные точки

• 3D knee kinematic assessment [Срок оценки: 1 day]
• Precision of guided surgical actions [Срок оценки: During surgery]
• Precision of guided surgical actions [Срок оценки: On post-operative imaging (six weeks after surgery)]

Вторичные конечные точки (6)

• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
• Clinical results [Срок оценки: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]

Критерии участия

Критерии включения

• Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))

Критерии исключения

• Active infection
• Atypical morphology and/or alignment of the lower limbs
• Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
• Knee flexion contracture of 10 degrees or more
• Knee flexion of less than 120 degrees

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal

Идентификаторы

NCT: NCT01674816 · CE12.006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗