The Natural History of Congenital Trigger Thumbs
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah
First received: August 25, 2011
Last updated: January 9, 2014
Last verified: January 2014
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
||Observational Model: Case-Only
Time Perspective: Prospective
||The Natural History of Congenital Trigger Thumbs
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 ] [ Designated as safety issue: No ]
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424995
|Univeristy of Utah Orthopedic Center
|Salt Lake City, Utah, United States, 84108 |
University of Utah
||Douglas T Hutchinson, MD
||University of Utah Orthopedics
No publications provided
||Douglas Hutchinson, M.D., University of Utah
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 25, 2011
||January 9, 2014
||United States: Institutional Review Board
Keywords provided by University of Utah:
flexor pollicis longus tendon of the thumb
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Trigger Finger Disorder