Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460922
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-21
Brief Title:
3D Printing Models in Surgical Planning of Osteotomies in Kienbocks Disease Stages II-III
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
3D Printing Models and Personalized Guides in Surgical Planning of Shortening Wedge and Dorsolateral Biplane Closing Osteotomies in Kienbocks Disease Stages II and III
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ischemic necrosis of lunate bone osteonecrosis or Kienböcks disease was described by Kienböck in 1910 Numerous surgical procedures for this disease had been proposed These surgical options that depends of the radiological stage and anatomical risk factors can be classified into lunate unloading procedures lunate revascularization replacement procedures and salvage procedures These procedures except the salvage procedures has been successful in reconstructing and maintaining the height of the carpus avoiding progression of the disease and with reduction of the pain
The lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis
The lunate unloading procedures are surgical treatments that make a radial osteotomy for modify differents anatomical risk factors associated with the osteonecrosis
Detailed Description:
The anatomical factors associated with Kienböcks disease are morphology of the lunate type I by Antuña-Zapico cubitus minus radial inclination angle greater than 23º and little coverage of the lunate by the radius
The types of radial osteotomy for Kienböcks disease stages II IIIA IIIB or IIIC depends to the anatomy of the patient and its anatomical risk factors For patients with cubitus minus the indication is usually a radial shortening osteotomy For patients with zero variant and an increase in the radial inclination angle the indication is usually a closed wedge radial osteotomy The dorsolateral biplane radial osteotomy is used for zero variant cases such as a modification of the technique proposed by Nakamura et and Miura et al It decompresses the lunate on the frontal plane and reduces dorsal radiolunate impingement on hyperextension Dorsolateral radial osteotomy ensures a reduction of the radial inclination angle and a corresponding lunate decompression on the anteroposterior and sagittal plane
The types of radial osteotomy for Kienböcks disease stages II IIIA IIIB or IIIC depends to the anatomy of the patient and its anatomical risk factors For patients with cubitus minus the indication is usually a radial shortening osteotomy For patients with zero variant and an increase in the radial inclination angle the indication is usually a closed wedge radial osteotomy The dorsolateral biplane radial osteotomy is used for zero variant cases such as a modification of the technique proposed by Nakamura et and Miura et al It decompresses the lunate on the frontal plane and reduces dorsal radiolunate impingement on hyperextension Dorsolateral radial osteotomy ensures a reduction of the radial inclination angle and a corresponding lunate decompression on the anteroposterior and sagittal plane
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None