Radial ClubhandNCT03432052
Clinical and Radiological Outcomes of Centralization of Radial Club Hand
An observational study of Radial Clubhand, run by Assiut University.
Trial summary
Assess the recurrence of deformity after wrist Centralization in cases of radial club hand and effect of the procedure on the ulnar lengthening , ulnar bowing , hand function and parent satisfaction. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Radial Clubhand
- What is being tested?
- centralization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Apr 2019
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients which had done centralization in our department who are available for follow up with complete records within the past 10 years.
Who may be able to join
- All patients which had done centralization in our department who are available for follow up with complete records within the past 10 years.
- Cases with radial club hand Grade 3, 4 according to Bayne-Klug classification.
- Follow up duration should be at least two years.
Who cannot join
- Patients with follow up less than 2 years.
- Cases with Radial club hand Grade 1 , 2 according to Bayne-Klug classification
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiological Outcomes of Centralization as a Surgical Management for Radial Club Hand
Assess the recurrence of deformity after wrist Centralization in cases of radial club hand and effect of the procedure on the ulnar lengthening , ulnar bowing , hand function and parent satisfaction.
Read the detailed description
Radial club hand is a deficiency along the radial side of the extremity. Although considerable forearm and hand anomalies are the classic findings, proximal deficiencies also can occur throughout the arm and shoulder girdle. The elbow abnormalities can include deficiences of the olecranon, capitellum, coronoid fossa, and medial epicondyle.
In 1733, Petit first described radial club hand in an autopsy of a neonate with bilateral club hands and absent radii.
Initial surgical treatment of radial club hand involved an ulnar osteotomy to correct the bow, along with splitting of the distal ulna for insertion of the carpus. Reconstruction of the radius with a bone graft to support the carpus was reported in the 1920s, and non-vascularized epiphyseal transfer was reported in 1945. Results of these procedures were disappointing. They had multiple causes of failure, including disruption of the ulnar growth plate and subsequent increase in limb-length discrepancy, inadvertent ankylosis or arthrodesis of the wrist and loss of motion, and failure of the transplanted bone to grow, with eventual loss of radial support.
Centralization of the carpus on the distal ulna has emerged as the preferred surgical technique for correcting radial clubhand.in 1893, Sayre described it consisting of seating the distal ulna into a surgically created carpal notch. Pioneers in congenital hand surgery developed the basis for this procedure. Numerous modifications have been described to obtain or maintain correction of the wrist on the ulna.
Wrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a a small Steinmann pin through the middle finger metacarpal , carpus ,and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist.
- Conditions
- Radial Clubhand
- Being tested
- centralization
- Keywords
- centralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
centralizationProcedure or surgery
Wrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a small Steinmann pin through the middle finger metacarpal, carpus, and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist.
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of wrist deformity
HFA more than 10 degrees as Vilkki HWO severity grading for radial dysplasia consider 10 degrees is the cut-off point for mild deformity.The hand-forearm-angle (HFA) is defined as the acute intersecting angle between the longitudinal axis of the third metacarpal and a line drawn perpendicular to the distal physis of the ulna
Measured: at least 2 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial ClubhandStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Taher Alaa Eldin Ahmed Eid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432052
- Sponsor's protocol ID
- radial club hand
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Centralization as a Surgical Management for Radial Club Hand
- ClinicalTrials.gov ID
- NCT03432052
- Acronym / sponsor ID
- radial club hand
- Conditions
- Radial Clubhand
- Keywords
- centralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 13 Feb 2018 (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.
Assess the recurrence of deformity after wrist Centralization in cases of radial club hand and effect of the procedure on the ulnar lengthening , ulnar bowing , hand function and parent satisfaction.
Detailed description
Radial club hand is a deficiency along the radial side of the extremity. Although considerable forearm and hand anomalies are the classic findings, proximal deficiencies also can occur throughout the arm and shoulder girdle. The elbow abnormalities can include deficiences of the olecranon, capitellum, coronoid fossa, and medial epicondyle.
In 1733, Petit first described radial club hand in an autopsy of a neonate with bilateral club hands and absent radii.
Initial surgical treatment of radial club hand involved an ulnar osteotomy to correct the bow, along with splitting of the distal ulna for insertion of the carpus. Reconstruction of the radius with a bone graft to support the carpus was reported in the 1920s, and non-vascularized epiphyseal transfer was reported in 1945. Results of these procedures were disappointing. They had multiple causes of failure, including disruption of the ulnar growth plate and subsequent increase in limb-length discrepancy, inadvertent ankylosis or arthrodesis of the wrist and loss of motion, and failure of the transplanted bone to grow, with eventual loss of radial support.
Centralization of the carpus on the distal ulna has emerged as the preferred surgical technique for correcting radial clubhand.in 1893, Sayre described it consisting of seating the distal ulna into a surgically created carpal notch. Pioneers in congenital hand surgery developed the basis for this procedure. Numerous modifications have been described to obtain or maintain correction of the wrist on the ulna.
Wrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a a small Steinmann pin through the middle finger metacarpal , carpus ,and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients which had done centralization in our department who are available for follow up with complete records within the past 10 years.
Key inclusion criteria (3 listed)
- All patients which had done centralization in our department who are available for follow up with complete records within the past 10 years.
- Cases with radial club hand Grade 3, 4 according to Bayne-Klug classification.
- Follow up duration should be at least two years.
Key exclusion criteria (2 listed)
- Patients with follow up less than 2 years.
- Cases with Radial club hand Grade 1 , 2 according to Bayne-Klug classification
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 |
|---|---|---|
| centralizationWrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a small Steinmann pin through the middle finger metacarpal, carpus, and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist. | Procedure or surgery | – |
Primary outcome
recurrence of wrist deformity
Time frame: at least 2 years of follow up
HFA more than 10 degrees as Vilkki HWO severity grading for radial dysplasia consider 10 degrees is the cut-off point for mild deformity.The hand-forearm-angle (HFA) is defined as the acute intersecting angle between the longitudinal axis of the third metacarpal and a line drawn perpendicular to the distal physis of the ulna
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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 Radial Clubhand, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2018. 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 El-Taher Alaa eid, Resident (01004859149, taheralaa92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of wrist deformity (time frame: at least 2 years of follow up). 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 13 Feb 2018.