Return to Sport After Posterior Spinal Fusion

Return to Sport After Posterior Spinal Fusion in Adolescent Athletes With Idiopathic Scoliosis: a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All enrolled subjects will be competitive athletes with a diagnosis of adolescent idiopathic scoliosis and plans to undergo posterior spinal fusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to Sport	Identify at what time patients return to sports without any restrictions.	Less than 1 year following surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Study Director: Sumeet Garg, MD, Children's Hospital Colorado; Principal Investigator: Allison Tetreault, MD, University of Colorado School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent Idiopathic Scoliosis; Return to Sport; Posterior Spinal Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 17-2473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No