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The Natural History of Congenital Trigger Thumbs

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. Identifier: NCT01424995
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah

Brief Summary:
This will be a prospective study of all children ages 0 - 5 years old at the time of entry into the study that meet the inclusion criteria who present with congenital trigger thumb. Patient records will be reviewed for eligibility before obtaining parental permission. They will be enrolled in the study at their first visit and followed every year for up to 4 years or until one of the exclusion criteria are met. Participating sites include the University of Utah Orthopaedic Center, Primary Children's Medical Center and Shriners Hospital for Children.

Condition or disease
Congenital Trigger Thumb Tenosynovitis

Detailed Description:
Trigger thumb is a stenosis tenosynovitis of the flexor pollicis longus tendon of the thumb1. The eitiology of congenital trigger thumb is unclear with many authors proposing both hereditary and acquired causes2-4. Surgical release of congenital trigger thumbs has been recommended as definitive treatment, though controversy exists over the natural history of congenital trigger thumbs5-8. There have been a number of studies looking at the natural history of congenital trigger thumbs with spontaneous resolution rates ranging from 0-96% over a median duration of follow up that ranged from 6 months to 48 months9-14. Based on our clinical experience, the investigators do not feel that congenital trigger thumbs resolve spontaneously and that definitive treatment requires surgical release. However, the investigators need to do further scientific research into the natural history of trigger thumbs to determine how often trigger thumb resolves without needing surgical intervention.

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Natural History of Congenital Trigger Thumbs
Study Start Date : December 2010
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The goal of this study is to prospectively evaluate the natural history of congenital trigger thumbs to determine the true incidence of spontaneous resolution. [ Time Frame: 4 years ]
    The following physical exam measurements will be made at the first visit and all subsequent visits until completion of the study: flexion contracture of the interphalangeal joint of both thumbs (resolution of deformity defined as when flexion contracture is 0°), metacarpal-phalangeal joint laxity, and amount interphalangeal joint angular deformity.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will evaluate all patients who present to our institution with congenital trigger thumb over a one year period and choose not to have a surgical intervention

Inclusion Criteria:

  • Diagnosis of congenital trigger thumb based on physical exam and history, no previous treatment history (either operative or non-operative), no pain associated with the deformity, no functional disability due to the trigger thumb.

Exclusion Criteria:

  • Previous operative treatment for the congenital trigger thumb, deformity of the thumb that causes pain, triggering that causes secondary deformity of the thumb, and deformity that prevents normal use of the thumb and hand.

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 identifier (NCT number): NCT01424995

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United States, Utah
Univeristy of Utah Orthopedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
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Principal Investigator: Douglas T Hutchinson, MD University of Utah Orthopedics

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Responsible Party: Douglas Hutchinson, M.D., University of Utah Identifier: NCT01424995     History of Changes
Other Study ID Numbers: 32047
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Keywords provided by Douglas Hutchinson, University of Utah:
trigger thumb
flexor pollicis longus tendon of the thumb
stenosis tenosynovitis
Additional relevant MeSH terms:
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Trigger Finger Disorder
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment