Return to Sport After Posterior Spinal Fusion

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513120
• Other study ID #: 17-2473
• Status: Completed
• Start date: March 8, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: December 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Posterior Spinal Fusion
• Scoliosis

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to Sport	Identify at what time patients return to sports without any restrictions.	Less than 1 year following surgery
Secondary	Physical Function Levels	Identify at what time patients report physical function returns to their pre-surgical levels.	Less than 1 year following surgery
Secondary	Postoperative Complications	Identify any postoperative complications related to release to full activity one month after surgery.	Up to 1 year follow up