Actively Recruiting

Age: 18Years - 85Years
All Genders
ID06460922

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

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2026-05-12

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

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AI-Summary

What this Trial Is About

Kienbock's disease, a condition involving ischemic necrosis of the lunate bone, has several surgical treatments depending on the disease stage and anatomical risk factors. This research focuses on stages II and III of the disease. Various surgeries aim to unload the lunate bone, restore its blood supply, or replace damaged parts, with most options working to maintain wrist structure, prevent disease progression, and reduce pain. This study evaluates the use of 3D printing models and personalized guides to plan different types of radial osteotomies tailored to patients' anatomical features. These osteotomies include radial shortening, closed wedge, and dorsolateral biplane closing osteotomies, chosen based on factors like cubitus minus and radial inclination angle. The procedures involve osteosynthesis with a plate on the distal radius to decompress and protect the lunate bone. Participants will undergo clinical and radiological evaluations before and after surgery, including assessments of wrist function, pain, grip strength, and range of motion. Radiographic measurements such as Lichtman classification, carpal height ratio, and various wrist angles will be monitored over 22 months. These evaluations aim to track changes related to the surgical planning aided by 3D models, with ongoing follow-up to assess outcomes and recovery.

CONDITIONS

Brief Title

3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Kienbock's disease in the wrist at stages II, IIIA, IIIB, or IIIC by Lichtman classification
  • Age between 18 and 85 years old
Not Eligible

You will not qualify if you...

  • Kienbock's disease at pre-radiological stage I
  • Radiocarpal and midcarpal osteoarthritis, Lichtman stage IV
  • Age less than 18 years
  • Age greater than 85 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Surgery day and initial recovery period

Participants undergo radial osteotomy surgery planned with 3D printing models and personalized guides, followed by immediate post-operative care.

1 surgical visit (in-person) and immediate post-operative care visits

Post-operative Follow-up

Duration - Up to 22 months

Participants are monitored through clinical and radiological evaluations to assess recovery and outcomes after surgery.

Multiple follow-up visits throughout recovery

Trial Site Locations

Total: 1 location

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain, 08041

Actively Recruiting

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Research Team

C

Claudia Lamas, MD, PhD

A

Alejandra Guerrero-Espinosa, MD, Ph D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial