Return to Sport After Posterior Spinal Fusion

Completed

• Conditions: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

• Registration Number: NCT03513120
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The primary purpose of this prospective study is to determine when adolescent athletes with idiopathic scoliosis are able to return to sports participation after posterior spinal fusion surgery.

Detailed Description

The investigators aim to determine at what time subjects return to athletic activity, and how long after surgery they are performing at pre-surgical levels. The investigators will enroll adolescent athletes that meet the inclusion criteria below, and follow their postoperative activity level with standardized activity questionnaires on a monthly basis until the subject reaches their baseline pre-surgical performance level. The investigators primary aim is to determine at what time patients return to sports without any restrictions to contact level or type of play. The investigators secondary aim is to quantitatively assess when patients are able to compete at their prior level of play as determined by self-assessment surveys, as well as identify any post-operative complications in these patients after return to sports.

Study Timeline

• Study Start: 2018-03-08
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Level of play: high school or club level
• Frequency of play at above level: >3mos/year
• Age: 10-18 years of age (inclusive)
• Sports: at least one sport, contact, non-contact, or collision. No sports exclusion criteria
• Spinal deformity criteria: Adolescent idiopathic scoliosis, curve size 40-75 degrees

Exclusion Criteria

• Play at recreational/intramural level
• Non-English Speaking Patient
• Sports participation <3 mos/year
• Non idiopathic etiology or curves >75 degrees
• Treatment outside of Children's Hospital Colorado provider care network

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Return to Sport	Less than 1 year following surgery	Identify at what time patients return to sports without any restrictions.

Secondary Outcome Measures

Name	Time	Method
Physical Function Levels	Less than 1 year following surgery	Identify at what time patients report physical function returns to their pre-surgical levels.
Postoperative Complications	Up to 1 year follow up	Identify any postoperative complications related to release to full activity one month after surgery.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States