The Natural History of Congenital Trigger Thumbs

NCT ID: NCT01424995

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Congenital Trigger Thumb; Tenosynovitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Douglas Hutchinson

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas T Hutchinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopedics

Locations

Univeristy of Utah Orthopedic Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

32047

Identifier Type: -

Identifier Source: org_study_id