Orthopedic DisorderNCT05212324
Management of Congenial Clasped Thumb
An observational study of Orthopedic Disorder, run by Al-Azhar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- widening of first web space
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2022to Apr 2024
- 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 2 to 8 years
- All sexes
- Child
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
Who may be able to join
- Congenital clasped thumb
- Cerebral palsy
- Arthrogryposis
- Under age of eight years old.
Who cannot join
- 1- Congenital trigger thumb. 2- Neglected adducted thumb. 3- Post traumatic extensor tendon injury. 4- Neglected congenital clasped thumb.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Different Modalities in Management of Congenial Clasped Thumb
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
Read the detailed description
The main problem is the deficient extensor tendon mechanism of thumb due to functional and structural causes. \
Although in congenital clasp finger deformity there are thumb flexion deformity due to extensor tendon insufficiency and muscle and skin contractions at flexor and thenar regions.
In congenital clasped thumb success of treatment depends on lesion type. Although successful results have been obtained with splinting and conservative treatment, several reconstruction methods are used due to secondarily developed contractures in neglected cases. Tendon transfers are useful in hypermobile thumb cases who have both extensor and opponents tendon deficiency.
- Conditions
- Orthopedic Disorder
- Being tested
- widening of first web space
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
widening of first web spaceProcedure or surgery
widening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon
| Study group | Role | What they receive |
|---|---|---|
| widening | widening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon Receives: Procedure: widening of first web space |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start11 Feb 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abdelkader Abdelwahed Mohammed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212324
- Sponsor's protocol ID
- MCCT
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shreve M, Chu A. Pediatric Thumb Flexion Deformities. Bull Hosp Jt Dis (2013). 2016 Mar;74(1):97-108.
PubMed 26977555
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Modalities in Management of Congenial Clasped Thumb
- ClinicalTrials.gov ID
- NCT05212324
- Acronym / sponsor ID
- MCCT
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 11 Feb 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- 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.
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
Detailed description
The main problem is the deficient extensor tendon mechanism of thumb due to functional and structural causes. \
Although in congenital clasp finger deformity there are thumb flexion deformity due to extensor tendon insufficiency and muscle and skin contractions at flexor and thenar regions.
In congenital clasped thumb success of treatment depends on lesion type. Although successful results have been obtained with splinting and conservative treatment, several reconstruction methods are used due to secondarily developed contractures in neglected cases. Tendon transfers are useful in hypermobile thumb cases who have both extensor and opponents tendon deficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| widening | – | Procedure: widening of first web spacewidening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- Congenital clasped thumb
- Cerebral palsy
- Arthrogryposis
- Under age of eight years old.
Key exclusion criteria (1 listed)
- 1- Congenital trigger thumb. 2- Neglected adducted thumb. 3- Post traumatic extensor tendon injury. 4- Neglected congenital clasped thumb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| widening of first web spacewidening of first web space by flaps, tendon transfer to extensor policis longus tendon, fractional lengthening of flexor policis longus tendon | Procedure or surgery | widening |
Primary outcome
improved hand grip degree
Time frame: 3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 26977555Shreve M, Chu A. Pediatric Thumb Flexion Deformities. Bull Hosp Jt Dis (2013). 2016 Mar;74(1):97-108.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Al-Azhar University.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tamer abdelkader, MD (01006583097, TamerAbdElkader.216@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved hand grip degree (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05212324, which also lists 1 linked publication.
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 28 Jan 2022.