NCT02237248

Function and Scoliosis Surgery

Functional Testing, and Biomechanics Before and After Scoliosis Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS).

Detailed description

Methods will consist of movement studies, questionnaires, and chart review. The recruited subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and 12-month post-operative follow-up visits. After signing informed consent, age at time of surgery, height, weight, body composition, leg length will be recorded to be used during data processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis classification, instrumentation used during surgery, and level of spinal fusion. All subjects will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score), general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and left lateral bending, and right and left trunk rotation. These measures will be assessed preoperatively and at postoperative follow-up visits.

Conditions

• Adolescent Idiopathic Scoliosis

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-06-19
• Completion: 2017-06-19
• First posted: 2014-09-11
• Last updated: 2017-06-28

Locations

1 site across 1 country: United States