Clinical and Radiological Outcomes of Centralization as a Surgical Management for Radial Club Hand

Clinical and Radiological Outcomes of Centralization of Radial Club Hand



Sponsors

Lead Sponsor



Source

Assiut University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Not yet recruiting

Start Date

2018-03-01

Completion Date

2019-04-01

Primary Completion Date

2019-03-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

recurrence of wrist deformity
at least 2 years of follow up

Enrollment

10

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

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.


Eligibility

Study Pop

All patients which had done centralization in our department who are available for follow
up with complete records within the past 10 years.

Sampling Method

Non-Probability Sample

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

Gender

All

Minimum Age

6 Months

Maximum Age

3 Years

Healthy Volunteers

No


Overall Contact

Last Name

El-Taher Alaa eid, Resident

Phone

01004859149

Email



Verification Date

2018-02-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Assiut University

Investigator Full Name

El-Taher Alaa Eldin Ahmed Eid

Investigator Title

principle Iinvestigator


Keyword


Has Expanded Access

No

Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Tarek Abdallah elgammal, professor

Phone

01005229293

Email



Patient Data

Sharing Ipd

Yes


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Only

Time Perspective

Retrospective


Study First Submitted

February 2, 2018

Study First Submitted Qc

February 12, 2018

Study First Posted

February 13, 2018

Last Update Submitted

February 12, 2018

Last Update Submitted Qc

February 12, 2018

Last Update Posted

February 13, 2018


ClinicalTrials.gov processed this data on August 29, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP