Skip to main content
OpenTrials
Completed

NCT Number: NCT03513120

Return to Sport After Posterior Spinal Fusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Return to Sport

    Time frame: Less than 1 year following surgery

    Identify at what time patients return to sports without any restrictions.

Secondary outcomes

  1. Physical Function Levels

    Time frame: Less than 1 year following surgery

    Identify at what time patients report physical function returns to their pre-surgical levels.

  2. Postoperative Complications

    Time frame: Up to 1 year follow up

    Identify any postoperative complications related to release to full activity one month after surgery.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 1, 2018
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.