Congenital Limb Anomaly NosNCT05182333
Congenital Hand and Upper Extremity Malformations
An observational study of Congenital Limb Anomaly Nos, run by Assiut University.
Trial summary
Getting the incidence of upper limb anomalies in our department from 2000 to 2020 and classifying them using IFSSH classification and OMT classification Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Limb Anomaly Nos
- What is being tested?
- Examination
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Jul 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with congenital upper limb anomalies
Who may be able to join
- All patients with congenital upper limb anomalies in last 20 years in Assiut university hospital.
Who cannot join
- Conditions that were considered to be difficult to correctly classify because of late presentation, a large span of clinical presentation, extremely rare conditions, and conditions difficult to differentiate from traumatic conditions were excluded (ie, congenital radial head dislocation, congenital tumorous conditions, Marfan syndrome)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Study for Congenital Hand and Upper Extremity Malformations in Assiut University Hospital During the Last Twenty Years
Getting the incidence of upper limb anomalies in our department from 2000 to 2020 and classifying them using IFSSH classification and OMT classification
Read the detailed description
A retrospective look at the past 20 years illustrated the changes and developments that characterize the world of hand surgery. During these years, old techniques were developed and standardized, new surgical techniques were described, our knowledge improved and illustrated by better classification systems, and new ideas were born that would guide the future of hand surgery. Limb deformities are among the most common birth defects in infants. Over the past 150 years, many classifications of limb abnormalities based on bone morphology and anatomy have been developed.
Congenital anomalies of the hand require consistent and reproducible terminology, and it is a universal language that allows discussion of complex clinical entities, treatment indications and outcome comparisons.
Ideally, the classification of congenital anomalies of the hand will depend on the etiology, giving some indication of the location in the molecular pathway and / or the anatomical location in the developing limb bud where the error occurs and the moment when the fault occurs. The terms should be understandable to geneticists, anatomists, pathologists, and surgeons, and they should allow easy interpretation to parents and, where appropriate, children affected by these conditions. The classification of congenital anomalies of the upper extremity and the important association of these anomalies with systemic disorders and syndromes are described in this study. Depending on the classification, examples are given for each class of anomalies.
- Conditions
- Congenital Limb Anomaly Nos
- Being tested
- Examination
- Keywords
- Congenital upper limb anomalies
- Medical subject headings
- Limb Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationOther
History taking, examination of upper limb
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of anomalies
Getting the incidences of the upper limb anomalies in upper Egypt
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Limb Anomaly NosStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Magdy Makar Salieb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182333
- Sponsor's protocol ID
- Congenital UL anomalies
- Status last verified
- Dec 2021
- First submitted
- 28 May 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Congenital Hand and Upper Extremity Malformation in Upper Egypt-during the Last Twenty Years
Publications
McCarroll HR. Congenital anomalies: a 25-year overview. J Hand Surg Am. 2000 Nov;25(6):1007-37. doi: 10.1053/jhsu.2000.6457.
PubMed 11119659Tayel SM, Fawzia MM, Al-Naqeeb NA, Gouda S, Al Awadi SA, Naguib KK. A morpho-etiological description of congenital limb anomalies. Ann Saudi Med. 2005 May-Jun;25(3):219-27. doi: 10.5144/0256-4947.2005.219.
PubMed 16119523
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study for Congenital Hand and Upper Extremity Malformations in Assiut University Hospital During the Last Twenty Years
- ClinicalTrials.gov ID
- NCT05182333
- Acronym / sponsor ID
- Congenital UL anomalies
- Conditions
- Congenital Limb Anomaly Nos
- Keywords
- Congenital upper limb anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 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.
Getting the incidence of upper limb anomalies in our department from 2000 to 2020 and classifying them using IFSSH classification and OMT classification
Detailed description
A retrospective look at the past 20 years illustrated the changes and developments that characterize the world of hand surgery. During these years, old techniques were developed and standardized, new surgical techniques were described, our knowledge improved and illustrated by better classification systems, and new ideas were born that would guide the future of hand surgery. Limb deformities are among the most common birth defects in infants. Over the past 150 years, many classifications of limb abnormalities based on bone morphology and anatomy have been developed.
Congenital anomalies of the hand require consistent and reproducible terminology, and it is a universal language that allows discussion of complex clinical entities, treatment indications and outcome comparisons.
Ideally, the classification of congenital anomalies of the hand will depend on the etiology, giving some indication of the location in the molecular pathway and / or the anatomical location in the developing limb bud where the error occurs and the moment when the fault occurs. The terms should be understandable to geneticists, anatomists, pathologists, and surgeons, and they should allow easy interpretation to parents and, where appropriate, children affected by these conditions. The classification of congenital anomalies of the upper extremity and the important association of these anomalies with systemic disorders and syndromes are described in this study. Depending on the classification, examples are given for each class of anomalies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with congenital upper limb anomalies
Key inclusion criteria (1 listed)
- All patients with congenital upper limb anomalies in last 20 years in Assiut university hospital.
Key exclusion criteria (1 listed)
- Conditions that were considered to be difficult to correctly classify because of late presentation, a large span of clinical presentation, extremely rare conditions, and conditions difficult to differentiate from traumatic conditions were excluded (ie, congenital radial head dislocation, congenital tumorous conditions, Marfan syndrome)
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 |
|---|---|---|
| ExaminationHistory taking, examination of upper limb | Other | – |
Primary outcome
Incidences of anomalies
Time frame: Baseline
Getting the incidences of the upper limb anomalies in upper Egypt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Background: PubMed 11119659McCarroll HR. Congenital anomalies: a 25-year overview. J Hand Surg Am. 2000 Nov;25(6):1007-37. doi: 10.1053/jhsu.2000.6457.
- Background: PubMed 16119523Tayel SM, Fawzia MM, Al-Naqeeb NA, Gouda S, Al Awadi SA, Naguib KK. A morpho-etiological description of congenital limb anomalies. Ann Saudi Med. 2005 May-Jun;25(3):219-27. doi: 10.5144/0256-4947.2005.219.
- Individual participant dataSharing planned: Undecided. Congenital Hand and Upper Extremity Malformation in Upper Egypt-during the Last Twenty Years
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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 Congenital Limb Anomaly Nos, run by Assiut 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 1 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 10 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 Shady Salieb, MD (+201028700865, shadymagdy93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of anomalies (time frame: Baseline). 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 NCT05182333, which also lists 2 linked publications.
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 10 Jan 2022.