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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01409980
Other study ID # 49246
Secondary ID
Status Completed
Phase N/A
First received August 2, 2011
Last updated June 22, 2014
Start date July 2011
Est. completion date June 2014

Study information

Verified date June 2014
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

A triphalangeal thumb is a thumb with three phalanges. The thumb often appears long and fingerlike, and can sometimes be in the same plane as the other fingers. Anatomically, the extra phalanx can have different shapes. Several classification systems have been used, but the simplest and most often used is the Wood (1976) classification by the shape of the extra phalanx. If the extra phalanx is triangularly shaped it is classified as a type I. Type II has a rectangular shaped extra phalanx but it has not developed as a full phalanx. Type III is a full extra phalanx.


Description:

A triphalangeal thumb is a thumb with three phalanges. The thumb often appears long and fingerlike, and can sometimes be in the same plane as the other fingers. Anatomically, the extra phalanx can have different shapes. Several classification systems have been used, but the simplest and most often used is the Wood (1976) classification by the shape of the extra phalanx. If the extra phalanx is triangularly shaped it is classified as a type I. Type II has a rectangular shaped extra phalanx but it has not developed as a full phalanx. Type III is a full extra phalanx.

Different treatment strategies have been developed based on the type of triphalangeal thumb. This project looks specifically at type I, or a delta phalanx. The goals of surgery in any type are to reconstruct the anatomic deformity with a stable, functional thumb while providing an acceptable appearance.

There is no consensus on how triphalangeal thumbs with a delta phalanx should be treated. Bunnell and Campbell in the 1940s advocated doing no surgery at all. Milch advocated excising the abnormal phalanx in the pediatric population but supporting non-operative treatment for the adult population. A potential unwanted result of excision has been an angulated joint. Buck-Gramcko proposed that excision of the delta phalanx combined with ligament reconstruction could give a better result than with excision alone.

Hovius recommended different treatment based on the age of presentation. For patients less than 6 years, he advocated excision of a transverse oval piece of skin, resection of the extra phalanx with reconstruction of the radial collateral ligament at the new IP joint, and lengthening of the ulnar collateral ligament. For patients older than 6 years, he advocates partial resection of the extra phalanx with correction of the angle and arthrodesis of the DIP joint. Usually, collateral ligament reconstruction is not necessary in these cases.

Horii et al reviewed 13 type I delta triphalangeal thumbs with no associated hand abnormalities. Surgical treatment for these patients consisted of excision of an accessory phalanx and the repair of the collateral ligament. The IP joint was temporarily fixed with Kirschner wires for 4-6 weeks. Mean follow-up was 8.9 years. All patients were satisfied with the improvement in appearance. The mean IP joint motion was 54 degrees. No patients complained of instability or pain in the IP joint. Only one patient had ten degrees of lateral bending. They recommend operating on these patients between ages 1-2 years, when the phalangeal epiphyses becomes clear. They felt that earlier excision allows for better joint adaptation. The children also will learn how to use their hands correctly.

Recently it has been debated that it is beneficial to wait to operate on these children until they are older, and their bones and joints have matured. At that point, an osteotomy could be performed. Although these results have not been published yet, several well-respected hand surgeons have concluded that their outcomes have been better on patients who have had delayed surgery.

In our institutions, children generally have their thumb reconstructed using a delta phalanx excision with repair of the ligament around 1 to 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Patients under age 18 with a delta, or type I, phalanx

- Surgical intervention at Primary Children's Hospital or Shriners Hospital by Dr. Angela Wang or Dr. Douglas Hutchinson consisting of delta phalanx excision and ligament reconstruction

Exclusion Criteria:

- Patients with type II or III triphalangeal thumb

- Patients undergoing a secondary or revision surgery as their first surgery at our institutions

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate the long-term outcomes of surgical treatment for children treated at Primary Children's Medical Center and Shriners Hospital with a delta phalanx. Outcomes being measured include objective measurements (stability of IP and MCP joints, ROM of IP and MCP joints, grip strength and key pinch) and subjective measurements (VAS for functionality, pain and appearance, and DASH). 1 year No