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

1. 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
2. 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)
3. 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
4. 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
5. 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
6. 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

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis of Lunate
• Intervention / Treatment: Procedure: Henry approach; volar approach; Procedure: dorsal approach

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age : 18-65 Years.
• Stages II & III.
• Ulna minus.

Exclusion Criteria:

• Teens.
• Serious medical condition.
• Stage I& IV.
• Sever osteoporosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: radial shortening	Procedure: Henry approach; volar approach; 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.
Active Comparator: capitate shortening	Procedure: dorsal approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Modified Mayo Wrist Score)	wrist pain ; hand grip; work status ; range of motion	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 5, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis
• Other Study ID Numbers: soh-med-23-01-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No