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

NCT ID: NCT05727696

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-10

Brief Summary

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

Conditions

Avascular Necrosis of Lunate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radial shortening

Group Type: ACTIVE_COMPARATOR

Henry approach; volar approach

Intervention Type: PROCEDURE

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.

capitate shortening

Group Type: ACTIVE_COMPARATOR

dorsal approach

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Alamir Mohamed Farrag

residant orthopedic departement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Other Identifiers

soh-med-23-01-10

Identifier Type: -

Identifier Source: org_study_id