NCT05212324

Brief Summary

Congenital clasped thumb is a rare progressive flexion and adduction deformity presenting with heterogenous congenital abnormalities.(1, 2) It is confused with trigger finger deformity due to fixated flexion deformity of the thumb. In congenital trigger finger entrapment is present at A1 pulley level due to fusiform enlargement of flexor pollicis longus tendon

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 11, 2022

Last Update Submit

January 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • improved hand grip degree

    Measure the degree of thumb motion and improve function of the thumb to restore function of the hand abduction of the thumb more than 40 degree

    3 months

Study Arms (1)

widening

widening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon

Procedure: widening of first web space

Interventions

widening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon

widening

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

when the patient diagnosed in our outpatient clinic as congenital clasped thumb we will prepare him or her to the operation after full investigation. surgical procedure through the skin incision designed to widen the web by flap then by do fractional lengthening of flexor policis longus tendon transfer ot extensor policis longus tendon

You may qualify if:

  • Congenital clasped thumb
  • Cerebral palsy
  • Arthrogryposis
  • Under age of eight years old.

You may not qualify if:

  • Congenital trigger thumb. 2- Neglected adducted thumb. 3- Post traumatic extensor tendon injury. 4- Neglected congenital clasped thumb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shreve M, Chu A. Pediatric Thumb Flexion Deformities. Bull Hosp Jt Dis (2013). 2016 Mar;74(1):97-108.

    PMID: 26977555BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 28, 2022

Study Start

February 11, 2022

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share