The Natural History of Congenital Trigger Thumbs

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah
ClinicalTrials.gov Identifier:
NCT01424995
First received: August 25, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition
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 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 ] [ 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: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424995

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

No publications provided

Responsible Party: Douglas Hutchinson, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01424995     History of Changes
Other Study ID Numbers: 32047
Study First Received: August 25, 2011
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tenosynovitis
Trigger Finger Disorder
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment

ClinicalTrials.gov processed this record on August 26, 2014