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Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers

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ClinicalTrials.gov Identifier: NCT02749760
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2016
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Toby, MD, University of Kansas Medical Center

Brief Summary:
This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis (FDS), and wrist flexion strength will be measured and correlated with upper extremity injuries and time missed from pitching. The investigators will also be measuring loss of strength over the season. The goal is to learn whether strength in these muscles prevents UCL injuries and finally whether these muscles can be strengthened to avoid such injuries.

Condition or disease Intervention/treatment Phase
Elbow Injuries Sprain Ulnar Collateral Ligament Upper Extremity Injuries Strain of Ulnar Collateral Ligament Complete Tear Ulnar Collateral Ligament Other: Strengthening program Other: Exercise program Not Applicable

Detailed Description:
The goal of this study is to assess whether the strengths of the secondary muscular stabilizers toward valgus stress at the elbow, the wrist flexors, flexor digitorum superficialis, and pronator teres emanating from the medial epicondyle, affect the incidence of ulnar collateral ligament injuries of the elbows in pitchers. Pitchers in the minor leagues of a single professional baseball club will have the strength of these secondary muscular stabilizers assessed and then correlated to ulnar collateral ligament injuries and time missed from baseball season and subsequent seasons. A secondary goal is to assess whether strengthening exercises targeted toward these muscular stabilizers of the elbow can decrease the incidence of ulnar collateral ligament injuries in young baseball pitchers. This could impact the field by changing the emphasis from reconstruction and rehabilitation of ulnar collateral ligament injuries to prevention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Effect of Dynamic Stabilizers for Valgus Stability of the Elbow in Professional Baseball Players
Study Start Date : February 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Minor league pitchers
Minor league pitchers from a single professional baseball organization. Strength tests of the elbows will be administered at spring training and end of season for 5 years. If strength correlates to injury, strengthening and exercise programs may be established to target the stabilizers of the elbows.
Other: Strengthening program
Strengthening programs may be established to target the stabilizers of the elbows

Other: Exercise program
Exercise program may be established to target the stabilizers of the elbows.




Primary Outcome Measures :
  1. The Correlation of Strength to UCL Injuries in Minor League Pitchers [ Time Frame: 5 years ]
    After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.


Secondary Outcome Measures :
  1. The Diminution of Strength in Minor League Pitchers [ Time Frame: 5 years ]
    We will measure the diminution of strength over the course of a baseball season.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pitchers that are currently on a minor league baseball team.

Exclusion Criteria:

  • Pitchers that currently have upper extremity injuries or are in active rehab for upper extremity injury.

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): NCT02749760


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: E B Toby, MD University of Kansas Medical Center

Publications:

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Responsible Party: Bruce Toby, MD, Professor and Chair, Dept of Orthopedic Surgery and Sports Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02749760     History of Changes
Other Study ID Numbers: STUDY00000174
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bruce Toby, MD, University of Kansas Medical Center:
Ulnar collateral ligament
elbow injuries
dynamic elbow stabilizers
Tommy John's procedure
elbow injuries in pitchers

Additional relevant MeSH terms:
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Wounds and Injuries
Arm Injuries