Clinical Trials

HARMS-AIS

Contact

Ashley Byrne

434-243-0289

AEB6Q@hscmail.mcc.virginia.edu

Inclusion Criteria

  • Male or Female
  • Ages: 10-21
  • Diagnosis of adolescent idiopathic scoliosis (AIS) for which surgery is recommended

Exclusion Criteria

  • Prior spinal surgery
  • MRI abnormalities
  • Neuromuscular or other co-morbidities
  • Thoracogenic or cardiogenic scoliosis
  • Associated syndrome or developmental delay
  • Unable/unwilling to firmly commit to returning for required follow-up visits the study.

Study Summary

  • First Erect – 4-6 weeks post-surgery
  • 6 months post-surgery
  • 12 months post-surgery
  • 24 months post-surgery
  • 5, 10, 15, 20, 25 years post-surgery

Pre-operative

  • Radiographs, SRS Questionnaire, Pulmonary Function Test, Trunk Shape Measures, Trunk Flexibility Evaluation, Clinical Photographs

First Erect

  • Radiographs, Rod Tracing, Trunk Shape Measures (if cannot collect at FE visit, please collect at 3 month routine care visit)

6 month visit

  • Radiographs, SRS Questionnaire, Trunk Shape Measures

1 year visit

  • Radiographs, SRS Questionnaire/Pregnancy Q, Trunk Shape Measures, Trunk Flexibility Evaluation, Clinical Photographs

2 year visit

  • Radiographs, SRS Questionnaire/Pregnancy Q, Pulmonary Function Test (when collected as a part of patient’s routine care), Trunk Shape Measures, Trunk Flexibility Evaluation, Clinical Photographs

5, 10, 15, 20, 25 year visits

  • Radiographs, SRS Questionnaire/Pregnancy Q, Pulmonary Function Test (if collected on Pre-Op visit), Trunk Shape Measures, Trunk Flexibility Evaluation, Clinical Photographs

Payment

  • $50 gift card at 2, 5 and 10 year follow-up
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