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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Natalie Pulido

(507) 538-3560

Pulido.Natalie@mayo.edu

More information

Publications

Publications are currently not available