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Clinical and Radiological Outcomes of Centralization of Radial Club Hand

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ClinicalTrials.gov Identifier: NCT03432052
Recruitment Status : Unknown
Verified February 2018 by El-Taher Alaa Eldin Ahmed Eid, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
El-Taher Alaa Eldin Ahmed Eid, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Radial Clubhand Procedure: centralization

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical and Radiological Outcomes of Centralization as a Surgical Management for Radial Club Hand
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Intervention Details:
  • Procedure: centralization
    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.


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with follow up less than 2 years.
  • Cases with Radial club hand Grade 1 , 2 according to Bayne-Klug classification

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432052


Contacts
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Contact: El-Taher Alaa eid, Resident 01004859149 taheralaa92@gmail.com
Contact: Tarek Abdallah elgammal, professor 01005229293 Tarek.elgammal@aun.edu.eg

Sponsors and Collaborators
Assiut University

Additional Information:
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Responsible Party: El-Taher Alaa Eldin Ahmed Eid, principle Iinvestigator, Assiut University
ClinicalTrials.gov Identifier: NCT03432052    
Other Study ID Numbers: radial club hand
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Taher Alaa Eldin Ahmed Eid, Assiut University:
centralization