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A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease

Primary Purpose

Avascular Necrosis of Lunate

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Henry approach; volar approach
dorsal approach
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avascular Necrosis of Lunate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age : 18-65 Years. Stages II & III. Ulna minus. Exclusion Criteria: Teens. Serious medical condition. Stage I& IV. Sever osteoporosis.

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

radial shortening

capitate shortening

Arm Description

Outcomes

Primary Outcome Measures

(Modified Mayo Wrist Score)
wrist pain ; hand grip; work status ; range of motion

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
February 5, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05727696
Brief Title
A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease
Official Title
A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Kienböck's disease refers to avascular necrosis of the lunate carpal bone, known as lunatomalacia. It was first recognized and described by Austrian radiologist Robert Kienböck's in 1910 The lunate is the central bone in the proximal row, and it articulates with the scaphoid, capitate, triquetrum, and occasionally the hamate. More proximally, the lunate is a component of the radiocarpal joint, and it also articulates with the ulna via the triangular fibrocartilage complex (TFCC) The exact cause of Kienböck's is not known, though there are thought to be a number of factors predisposing a person to Kienböck's. Although there is no evidence that Kienböck's disease is inherited, it is possible that unidentified genetic factors could contribute to the development of the condition, It is multifactorial, related to the following variables:Ulnar negative variance (or ulna minus),Vascular supply to the lunate bone,Lunatemorphology,Radial inclination angle,multiple wrist trauma Kienböck's disease is the second most common type of avascular necrosis of the carpal bones, preceded only by avascular necrosis of the scaphoid. The typically affected population is males aged 20-40 years Patients usually present with unilateral pain over the dorsal aspect of the wrist, limited wrist motion, weakness, or a combination of the three. Wrist extension and axial loading exacerbate pain. Symptoms range from mild to debilitating. It is rarely bilateral, and trauma is often absent. Physical examination commonly reveals wrist swelling, tenderness over the expected location of the lunate, synovitis, and loss of grip strength Kienböck's disease is a clinical and imaging diagnosis. Both radiography/computed tomography and magnetic resonance imaging (MRI) are highly specific. However, MRI is the most sensitive and detects radiographically occult cases

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Lunate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radial shortening
Arm Type
Active Comparator
Arm Title
capitate shortening
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Henry approach; volar approach
Intervention Description
Radial Shortening : Supine position, general anesthesia, volar approach, Henry approach, osteotomy 1 inch from radio-carpal joint surface, shortening 2.5 mm of distal shaft radius, fixation by small DCP or small T plate.
Intervention Type
Procedure
Intervention Name(s)
dorsal approach
Intervention Description
Capitate Shortening : Supine position, general anesthesia, dorsal approach, separation between 2nd and 3rd compartments of extensor tendons, osteotomy & shortening 2.5 mm of capitate, compression by Herpert screw.
Primary Outcome Measure Information:
Title
(Modified Mayo Wrist Score)
Description
wrist pain ; hand grip; work status ; range of motion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age : 18-65 Years. Stages II & III. Ulna minus. Exclusion Criteria: Teens. Serious medical condition. Stage I& IV. Sever osteoporosis.
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m amin, prof
Phone
0934602963
Email
portal@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease

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