Clinical trial NCT01424995: The Natural History of Congenital Trigger Thumbs
Official title: The Natural History of Congenital Trigger Thumbs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Trigger Thumb
Tenosynovitis
Keywords: trigger thumb
flexor pollicis longus tendon of the thumb
stenosis tenosynovitis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 101
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The goal of this study is to prospectively evaluate the natural history of congenital trigger thumbs to determine the true incidence of spontaneous resolution.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Univeristy of Utah Orthopedic Center
state: Utah
Study officials:
affiliation: University of Utah Orthopedics
name: Douglas T Hutchinson, MD
role: PRINCIPAL_INVESTIGATOR
References: