NCT02749760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

7.6 years

First QC Date

April 11, 2016

Last Update Submit

September 25, 2024

Conditions

Keywords

Ulnar collateral ligamentelbow injuriesdynamic elbow stabilizersTommy John's procedureelbow injuries in pitchers

Outcome Measures

Primary Outcomes (1)

  • The Correlation of Strength to UCL Injuries in Minor League Pitchers

    After measuring strength of elbow stabilizers for up to five years, we will determine whether strength correlates with UCL injuries.

    5 years

Secondary Outcomes (1)

  • The Diminution of Strength in Minor League Pitchers

    5 years

Study Arms (1)

Minor league pitchers

OTHER

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 programOther: Exercise program

Interventions

Strengthening programs may be established to target the stabilizers of the elbows

Minor league pitchers

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

Minor league pitchers

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (23)

  • Anz AW, Bushnell BD, Griffin LP, Noonan TJ, Torry MR, Hawkins RJ. Correlation of torque and elbow injury in professional baseball pitchers. Am J Sports Med. 2010 Jul;38(7):1368-74. doi: 10.1177/0363546510363402. Epub 2010 Apr 16.

    PMID: 20400752BACKGROUND
  • Azar FM, Andrews JR, Wilk KE, Groh D. Operative treatment of ulnar collateral ligament injuries of the elbow in athletes. Am J Sports Med. 2000 Jan-Feb;28(1):16-23. doi: 10.1177/03635465000280011401.

    PMID: 10653538BACKGROUND
  • Bruce JR, Andrews JR. Ulnar collateral ligament injuries in the throwing athlete. J Am Acad Orthop Surg. 2014 May;22(5):315-25. doi: 10.5435/JAAOS-22-05-315.

    PMID: 24788447BACKGROUND
  • Bruce JR, Hess R, Joyner P, Andrews JR. How much valgus instability can be expected with ulnar collateral ligament (UCL) injuries? A review of 273 baseball players with UCL injuries. J Shoulder Elbow Surg. 2014 Oct;23(10):1521-6. doi: 10.1016/j.jse.2014.05.015.

    PMID: 25220199BACKGROUND
  • Conte SA, Fleisig GS, Dines JS, Wilk KE, Aune KT, Patterson-Flynn N, ElAttrache N. Prevalence of Ulnar Collateral Ligament Surgery in Professional Baseball Players. Am J Sports Med. 2015 Jul;43(7):1764-9. doi: 10.1177/0363546515580792. Epub 2015 Apr 29.

    PMID: 25925603BACKGROUND
  • Costantino C, Vaienti E, Pogliacomi F. Evaluation of the peak torque, total work, average power of flexor-estensor and prono-supinator muscles of the elbow in baseball players. Acta Biomed. 2003 Aug;74(2):88-92.

    PMID: 14509917BACKGROUND
  • Davidson PA, Pink M, Perry J, Jobe FW. Functional anatomy of the flexor pronator muscle group in relation to the medial collateral ligament of the elbow. Am J Sports Med. 1995 Mar-Apr;23(2):245-50. doi: 10.1177/036354659502300220.

    PMID: 7778713BACKGROUND
  • Dugas JR, Ostrander RV, Cain EL, Kingsley D, Andrews JR. Anatomy of the anterior bundle of the ulnar collateral ligament. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):657-60. doi: 10.1016/j.jse.2006.11.009. Epub 2007 Jun 20.

    PMID: 17583541BACKGROUND
  • Erickson BJ, Chalmers PN, Bush-Joseph CA, Verma NN, Romeo AA. Ulnar Collateral Ligament Reconstruction of the Elbow: A Systematic Review of the Literature. Orthop J Sports Med. 2015 Dec 9;3(12):2325967115618914. doi: 10.1177/2325967115618914. eCollection 2015 Dec.

    PMID: 26740956BACKGROUND
  • Erickson BJ, Gupta AK, Harris JD, Bush-Joseph C, Bach BR, Abrams GD, San Juan AM, Cole BJ, Romeo AA. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014 Mar;42(3):536-43. doi: 10.1177/0363546513510890. Epub 2013 Dec 18.

    PMID: 24352622BACKGROUND
  • Erickson BJ, Nwachukwu BU, Rosas S, Schairer WW, McCormick FM, Bach BR Jr, Bush-Joseph CA, Romeo AA. Trends in Medial Ulnar Collateral Ligament Reconstruction in the United States: A Retrospective Review of a Large Private-Payer Database From 2007 to 2011. Am J Sports Med. 2015 Jul;43(7):1770-4. doi: 10.1177/0363546515580304.

    PMID: 26129959BACKGROUND
  • Fleisig GS, Andrews JR, Dillman CJ, Escamilla RF. Kinetics of baseball pitching with implications about injury mechanisms. Am J Sports Med. 1995 Mar-Apr;23(2):233-9. doi: 10.1177/036354659502300218.

    PMID: 7778711BACKGROUND
  • Hamilton CD, Glousman RE, Jobe FW, Brault J, Pink M, Perry J. Dynamic stability of the elbow: electromyographic analysis of the flexor pronator group and the extensor group in pitchers with valgus instability. J Shoulder Elbow Surg. 1996 Sep-Oct;5(5):347-54. doi: 10.1016/s1058-2746(96)80065-6.

    PMID: 8933456BACKGROUND
  • Haugstvedt JR, Berger RA, Berglund LJ. A mechanical study of the moment-forces of the supinators and pronators of the forearm. Acta Orthop Scand. 2001 Dec;72(6):629-34. doi: 10.1080/000164701317269076.

    PMID: 11817880BACKGROUND
  • Jones KJ, Dines JS, Rebolledo BJ, Weeks KD, Williams RJ, Dines DM, Altchek DW. Operative management of ulnar collateral ligament insufficiency in adolescent athletes. Am J Sports Med. 2014 Jan;42(1):117-21. doi: 10.1177/0363546513507695. Epub 2013 Oct 21.

    PMID: 24145949BACKGROUND
  • Keller RA, Steffes MJ, Zhuo D, Bey MJ, Moutzouros V. The effects of medial ulnar collateral ligament reconstruction on Major League pitching performance. J Shoulder Elbow Surg. 2014 Nov;23(11):1591-8. doi: 10.1016/j.jse.2014.06.033. Epub 2014 Aug 31.

    PMID: 25183663BACKGROUND
  • Laudner KG, Wilson JT, Meister K. Elbow isokinetic strength characteristics among collegiate baseball players. Phys Ther Sport. 2012 May;13(2):97-100. doi: 10.1016/j.ptsp.2011.06.007. Epub 2011 Aug 24.

    PMID: 22498150BACKGROUND
  • Lin F, Kohli N, Perlmutter S, Lim D, Nuber GW, Makhsous M. Muscle contribution to elbow joint valgus stability. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):795-802. doi: 10.1016/j.jse.2007.03.024. Epub 2007 Nov 1.

    PMID: 17936028BACKGROUND
  • Park MC, Ahmad CS. Dynamic contributions of the flexor-pronator mass to elbow valgus stability. J Bone Joint Surg Am. 2004 Oct;86(10):2268-74. doi: 10.2106/00004623-200410000-00020.

    PMID: 15466738BACKGROUND
  • Morrey BF, Tanaka S, An KN. Valgus stability of the elbow. A definition of primary and secondary constraints. Clin Orthop Relat Res. 1991 Apr;(265):187-95.

    PMID: 2009657BACKGROUND
  • Otoshi K, Kikuchi S, Shishido H, Konno S. The proximal origins of the flexor-pronator muscles and their role in the dynamic stabilization of the elbow joint: an anatomical study. Surg Radiol Anat. 2014 Apr;36(3):289-94. doi: 10.1007/s00276-013-1168-3. Epub 2013 Jul 25.

    PMID: 23884470BACKGROUND
  • Udall JH, Fitzpatrick MJ, McGarry MH, Leba TB, Lee TQ. Effects of flexor-pronator muscle loading on valgus stability of the elbow with an intact, stretched, and resected medial ulnar collateral ligament. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):773-8. doi: 10.1016/j.jse.2009.03.008. Epub 2009 May 31.

    PMID: 19487136BACKGROUND
  • Werner SL, Fleisig GS, Dillman CJ, Andrews JR. Biomechanics of the elbow during baseball pitching. J Orthop Sports Phys Ther. 1993 Jun;17(6):274-8. doi: 10.2519/jospt.1993.17.6.274.

    PMID: 8343786BACKGROUND

MeSH Terms

Conditions

Elbow Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • E B Toby, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Dept of Orthopedic Surgery and Sports Medicine

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 25, 2016

Study Start

February 1, 2014

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations