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The Natural History of Congenital Trigger Thumbs

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah Identifier:
First received: August 25, 2011
Last updated: August 11, 2017
Last verified: August 2017
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.

Congenital Trigger Thumb Tenosynovitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Natural History of Congenital Trigger Thumbs

Resource links provided by NLM:

Further study details as provided by Douglas Hutchinson, University of Utah:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01424995

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

Responsible Party: Douglas Hutchinson, M.D., University of Utah Identifier: NCT01424995     History of Changes
Other Study ID Numbers: 32047
Study First Received: August 25, 2011
Last Updated: August 11, 2017

Keywords provided by Douglas Hutchinson, University of Utah:
trigger thumb
flexor pollicis longus tendon of the thumb
stenosis tenosynovitis

Additional relevant MeSH terms:
Trigger Finger Disorder
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment processed this record on September 21, 2017