Return to Sport After Posterior Spinal Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03513120

Recruitment Status : Completed

First Posted : May 1, 2018

Last Update Posted : December 19, 2020

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

Study Description

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.

Condition or disease
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 Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	30 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Return to Sport After Posterior Spinal Fusion in Adolescent Athletes With Idiopathic Scoliosis: a Prospective Study
Actual Study Start Date :	March 8, 2018
Actual Primary Completion Date :	August 31, 2020
Actual Study Completion Date :	August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Adolescent idiopathic scoliosis

MedlinePlus related topics: Scoliosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Return to Sport [ Time Frame: Less than 1 year following surgery ]
Identify at what time patients return to sports without any restrictions.

Secondary Outcome Measures :

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.
Postoperative Complications [ Time Frame: Up to 1 year follow up ]
Identify any postoperative complications related to release to full activity one month after surgery.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513120

Locations

Layout table for location information

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

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Layout table for investigator information

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

More Information

Layout table for additonal information

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT03513120
Other Study ID Numbers:	17-2473
First Posted:	May 1, 2018 Key Record Dates
Last Update Posted:	December 19, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No IPD will be shared with other researchers

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University of Colorado, Denver:


Adolescent Idiopathic Scoliosis Posterior Spinal Fusion Return to Sport

Additional relevant MeSH terms:

Layout table for MeSH terms

Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases

To Top