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Multicenter Study Protocol: Pediatric Idiopathic Scoliosis (AIS) Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion – Decision Aid Construction

Overview

Información sobre este estudio

The purpose of this study is to capture and analyze video recordings of encounters between patients, families, and their surgeons as they discuss treatment options for scoliosis. Analysis of the recordings will be used to develop a shared decision-making tool.

This research effort will gather and analyze video footage to gain a more personal aspect of the decision-making process. As the patient and their families are being introduced to the options for surgical treatment there is an instinctual reaction to certain scenarios that may occur from both fusion and non -fusion surgical treatments. These verbal and non-verbal cues will then be analyzed by a group of specialists trained in developing decision aid tools for healthcare support.

The data will be used to develop a decision aid tool that will help support patients and clinicians to think, talk and feel through what is the best treatment plan for each patient as they are faced with the surgical options available.

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.

Inclusion Criteria:

  • Patients age ≥ 10 to < 22 with the diagnosis of idiopathic scoliosis being seen for scoliosis treatment (any skeletal maturity level, Risser 0-5).
  • Curves > 35 degrees, < 70 degrees.
  • Patient has consulted with a spine specialist regarding surgery of treatment of their scoliosis and surgery (fusion or non-fusion) has been considered, or the patient has undergone surgery for treatment of their scoliosis within the past three years.
  • English speaking with parent/guardian present and willing to participate.
  • Male and females.
  • Patients < 3 years postop fusion and/or tether.

Exclusion Criteria:

  • Individuals < 10 and over 22 years of age.
  • Non-English speaking.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Annalise Larson, M.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Natalie Pulido

(507) 538-3560

Pulido.Natalie@mayo.edu

More information

Publicaciones

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Otros temas en investigación

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CLS-20530346

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