- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409980
Triphalangeal Thumbs in the Pediatric Population: Long Term Outcomes Following Surgical Intervention
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
Cohorts and Interventions
Group / Cohort |
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Triphalangeal Thumb
A search will be performed using CPT code 26587 (reconstruction of a supernumerary digit) at both Primary Children's Hospital and Shriners to identify all patients who Dr. Wang and Hutchinson operated on with a delta phalanx.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the long-term outcomes of surgical treatment for children treated at Primary Children's Medical Center and Shriners Hospital with a delta phalanx.
Time Frame: 1 year
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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).
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Angela Wang, M.D., University of Utah Orthopedic Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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