Return to Sport After Posterior Spinal Fusion

NCT03513120 | Completed

• 1 other identifier: 17-2473
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

Keywords

Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion; Return to Sport

Outcome Measures

Primary Outcomes (1)

• Return to Sport

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

  Less than 1 year following surgery

Secondary Outcomes (2)

• Physical Function Levels

  Less than 1 year following surgery

• Postoperative Complications

  Up to 1 year follow up

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Level of play: high school or club level
• Frequency of play at above level: \>3mos/year
• Age: 10-18 years of age (inclusive)

You may not qualify if:

• Spinal deformity criteria: Adolescent idiopathic scoliosis, curve size 40-75 degrees
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Sumeet Garg, MD

  Children's Hospital Colorado

  STUDY DIRECTOR

• Allison Tetreault, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: March 8, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)