Clinical Trials Directory

Trials / Completed

CompletedNCT01424995

The Natural History of Congenital Trigger Thumbs

Status
Completed
Phase
Study type
Observational
Enrollment
101 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
5 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2010-12-01
Primary completion
2018-06-01
Completion
2018-06-01
First posted
2011-08-29
Last updated
2018-08-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01424995. Inclusion in this directory is not an endorsement.