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Return to Sport After Posterior Spinal Fusion

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ClinicalTrials.gov Identifier: NCT03513120
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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 Type : Observational
Estimated Enrollment : 50 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
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis




Primary Outcome Measures :
  1. 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 :
  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.



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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: AIS, 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

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


Contacts
Contact: Hannah Quick, BA 720-777-5809 hannah.quick@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Hannah Quick, BA    720-777-5809    hannah.quick@childrenscolorado.org   
Principal Investigator: Allison Tetreault, MD         
Sub-Investigator: Sumeet Garg, MD         
Sponsors and Collaborators
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

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

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:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases