Ensayos clínicos

Overview

Información sobre este estudio

The goal of this proposal is to perform a pilot study in a group of patients (N=20) who have been diagnosed with osteochondritis dissecans (OCD) of the humeral capitellum. This pilot study will allow us to assess the study design, recruitment process, participant retention, and measurement variabilities for planning future large-scale studies.

Osteochondritis Dissecans (OCD) is a joint defect in which a crack forms in subchondral bone leading to separation of subchondral bone and overlying cartilage from the bulk of the bone. For this pilot study, we will be focusing on OCD within the elbow, specifically on the surface of the humeral capitellum. Large studies performed in Japan found that between 2.2-3.4% of youth baseball players develop OCD of the humeral capitellum. While ultrasound is a widely available, low cost, and non-ionizing imaging modality, it is not commonly used for assessing OCD lesions due to the limitations of Delay-and-Sum (DAS) reconstruction algorithms, which are widely used in clinical ultrasound scanners. Future studies will aim to determine if a new ultrasound reconstruction algorithm, called Delay-Multiply-and-Sum (DMAS), can address the current obstacles of using clinical ultrasound to diagnose severity and monitor healing of OCD lesions. Upon completion of these studies, geometric characteristics of OCD lesions will be reliably quantified to better assess their severity using ultrasound pre- and post-treatment. With improved reliability of diagnosis and monitoring, physicians will prevent advancement of OCD lesions to higher grades, as defined by the International Cartilage Regeneration and Joint Preservation Society (ICRS), and better determine the outcomes of their treatments without the use of ionizing radiation or higher cost of other imaging modalities. To accomplish this goal, we will recruit patients who have been diagnosed with OCD via X-ray computed tomography (CT) or Magnetic Resonance Imaging (MRI) and will be undergoing surgery to repair the condition. Patients will have their affected and contralateral elbows scanned using ultrasound once before surgery and at 6 weeks and 3 months after surgery. The ultrasound scans will be performed using both clinical and research ultrasound systems. The ultrasound scans acquired by the research system will be reconstructed using clinical-standard Delay-and-Sum (DAS) and the new DMAS algorithms. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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