NCT03107533

Brief Summary

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2017Mar 2027

Study Start

First participant enrolled

March 30, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

March 31, 2017

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients who understand disease treatment as determined by analysis of video recording

    Video will be recorded then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic).

    Baseline

Study Arms (1)

Video recording of clinical visit

Investigators will enroll patients from the Department of Orthopedic Surgery for enrollment. The shared decision group will provide staff for data analysis.

Other: Video recording of clinical visit

Interventions

For patients and parents that are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options.

Video recording of clinical visit

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children and adults

You may qualify if:

  • Scoliosis curve \>40 degrees, \< 65 degrees
  • Risser score \> 2
  • Age \> 13 years

You may not qualify if:

  • Risser score of 0 or 1
  • Non-ambulatory scoliosis patients
  • Ages 12 year and under

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Noelle Larson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedics

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 11, 2017

Study Start

March 30, 2017

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations