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Completed

NCT Number: NCT01424995

The Natural History of Congenital Trigger Thumbs

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of Utah Orthopedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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