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Recruiting NCT06460922

NCT06460922 3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III

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Clinical Trial Summary
NCT ID NCT06460922
Status Recruiting
Phase —
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Condition Kienbock Disease
Study Type OBSERVATIONAL
Enrollment 20 participants
Start Date 2024-05-10
Primary Completion 2026-11-28

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 85 Years
Study Type OBSERVATIONAL
Interventions
Radial osteotomy

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 20 participants in total. It began in 2024-05-10 with a primary completion date of 2026-11-28.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Ischemic necrosis of lunate bone, osteonecrosis or Kienböck´s 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.

Eligibility 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

Contact & Investigator

Central Contact

Claudia Lamas, MD, PhD

✉ clamasg@santpau.cat

📞 935537032

Principal Investigator

Claudia Lamas, MD, Ph D

PRINCIPAL INVESTIGATOR

Research Institute IIB Sant Pau. Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau

Frequently Asked Questions

Who can join the NCT06460922 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Kienbock Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06460922 currently recruiting?

Yes, NCT06460922 is actively recruiting participants. Contact the research team at clamasg@santpau.cat for enrollment information.

Where is the NCT06460922 trial being conducted?

This trial is being conducted at Barcelona, Spain.

Who is sponsoring the NCT06460922 clinical trial?

NCT06460922 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The principal investigator is Claudia Lamas, MD, Ph D at Research Institute IIB Sant Pau. Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 20 participants.

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