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
About this trial
This is an interventional treatment trial for Avascular Necrosis of Lunate
Eligibility Criteria
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
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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