Using 3D printed models to plan surgery for Kienbock's disease
3D Printing Models and Personalized Guides in Surgical Planning of Shortening, Wedge and Dorsolateral Biplane Closing Osteotomies in Kienbock´s Disease Stages II and III.
This study is testing if using 3D printed models can help surgeons plan better surgeries for people with Kienbock's disease to improve wrist function and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06460922 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Kienbock's disease stages II-III, a condition characterized by ischemic necrosis of the lunate bone. It aims to evaluate the effectiveness of various radial osteotomy techniques tailored to individual anatomical risk factors associated with the disease. By utilizing 3D printed models, surgeons can better plan and execute these procedures, which are designed to alleviate pain and prevent disease progression. The study will assess the outcomes of these surgical interventions in improving wrist function and patient quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with Kienbock's disease classified as stages II, IIIA, IIIB, or IIIC.
Not a fit: Patients with pre-radiological stage I Kienbock's disease or those with advanced osteoarthrosis (stage IV) will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and pain relief for patients suffering from Kienbock's disease.
How similar studies have performed: While the use of 3D printing in surgical planning is gaining traction, this specific application in Kienbock's disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification Exclusion Criteria: * Pre-radiological stages-Lichtman stage I * Radiocarpal and midcarpal osteoarthrosis, Lichtman stage IV * Kienböck in children: less than 18 years * Adults years greater than 85 years old
Where this trial is running
Barcelona, Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Claudia Lamas, MD, Ph D — Research Institute IIB Sant Pau. Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau
- Study coordinator: Claudia Lamas, MD, PhD
- Email: clamasg@santpau.cat
- Phone: 935537032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.