Function and Scoliosis Surgery

Completed

• Conditions: Adolescent Idiopathic Scoliosis

• Registration Number: NCT02237248
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Study Start: 2014-11
• Status Verified: 2017-06
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Clinical diagnosis of idiopathic scoliosis
• Patients identified to undergo spinal fusion surgery
• Treated at Duke University Medical Center

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Exclusion Criteria

• Neuromuscular or congenital scoliosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Lower Quarter Y-Balance Test (YBT-LQ)	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively	The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
Change in Functional Movement Screen (FMS)	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively	The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.

Secondary Outcome Measures

Name	Time	Method
Change in Marx Activity Scale	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Tegner Activity Scale	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in EQ-5D	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in SRS-22	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States