Phalanx of Supernumerary Digit of HandNCT01409980
Triphalangeal Thumbs in the Pediatric Population: Long Term Outcomes Following Surgical Intervention
An observational study of Phalanx of Supernumerary Digit of Hand, run by University of Utah.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Phalanx of Supernumerary Digit of Hand
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients with type II or III triphalangeal thumb
- Patients undergoing a secondary or revision surgery as their first surgery at our institutions
About this study
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.
Read the 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.
- Conditions
- Phalanx of Supernumerary Digit of Hand
- Keywords
- delta phalanx, thumb reconstructed, triphalangeal thumbs
- Medical subject headings
- Triphalangeal Thumb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phalanx of Supernumerary Digit of HandStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Wang, University of Utah
- Investigators
- Angela Wang, M.D., Principal investigator, University of Utah Orthopedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409980
- Sponsor's protocol ID
- 49246
- Status last verified
- Jun 2014
- First submitted
- 2 Aug 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triphalangeal Thumbs in the Pediatric Population: Long Term Outcomes Following Surgical Intervention
- ClinicalTrials.gov ID
- NCT01409980
- Acronym / sponsor ID
- 49246
- Conditions
- Phalanx of Supernumerary Digit of Hand
- Keywords
- delta phalanx, thumb reconstructed, triphalangeal thumbs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with type II or III triphalangeal thumb
- Patients undergoing a secondary or revision surgery as their first surgery at our institutions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Wang, M.D. principal investigator
University of Utah Orthopedic Center
Questions about this trial
What is this clinical trial studying?
An observational study of Phalanx of Supernumerary Digit of Hand, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.