Kienbock DiseaseNCT06460922
3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III
An observational study of Kienbock Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kienbock Disease
- What is being tested?
- Radial osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients affected by lunate necrosis of the wrist, lunatomalacia, or Kienböck´s disease, stages II, IIIA, IIIB or IIIC by Lichtman classification, in which a distal radial osteotomy is indicated.
Who may be able to join
- Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Claudia Delgado, MD, +34935537634, cdelgadoe@santpau.cat
About this study
Official title: 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.
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.
Read the detailed description
The anatomical factors associated with Kienböck´s 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 Kienböck´s 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.
- Conditions
- Kienbock Disease
- Being tested
- Radial osteotomy
- Keywords
- Lunatomalacia, Kienböck´s disease, Radial osteotomy, Biplane radial osteotomy
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial osteotomyProcedure or surgery
3D printing models and personalized guides in surgical planning in distal radius osteotomies for Kienböck´s disease. Osteosynthesis with a plate in distal radius.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation preoperative and postoperative: Mayo Wrist Score
Modified Mayo Wrist Score (MWS). It is based on pain, range of motion, grip strength and function. Scores of 80 to 100 are considered excellent; 65 to 79, good; 50 to 64, moderate; and less than 50, poor.
Measured: 22 months
Disabilities of the arm, shoulder and hand score questionnaire
Disabilities of the arm, shoulder and hand score (Quick DASH) questionnaire. From 0 (better outcome) to 100% (worse outcome)
Measured: 22 months
Clinical evaluation preoperative and postoperative: Grip strength
Grip strength mesure with a Jamar dynamometer (in Kilograms).
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist: Lichtman classification
Lichtman´s Stage of lunate necrosis classification: 4 stages (1977). Better stage 1, worse stage 4.
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist: Carpal Ulnar Distance Ratio.
Carpal Ulnar Distance Ratio (mesure in millimeters) by McMurtry-Youm (1978). Outcomes in a ratio 0.30+-0.03.
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist. Carpal Height Ratio.
Carpal Height Ratio (measure in millimeters) by McMurtry-Youm (1978) . Outcomes in a ratio 0.54+-0.03.
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle.
The Radial Inclination Angle (RIA) describes the angulation of the distal radial articular surface in relationship with the long axis of the radius or ulna as seen in the posteroanterior view of the wrist. We measure RIA in relationship with the long axis of the ulna. The normal limits are 18.8° to 29.3° (measure in degrees).
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist: Lunate covering Ratio.
The Lunate Covering Ratio (LCR) is a measure of the lunate surface protected by the radius, obtained by dividing the width of lunate covered by radius by total lunate width in millimeters x 100.
Measured: 22 months
Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance.
Ulnar variance was measured as described by Gelberman et al. (1980) The measurement was obtained by projecting a line from the carpal joint surface of the distal end of the radius toward the ulna and measuring the distance in millimeters between this line and the carpal surface of the ulna. Ulnar shortening values of 2 or more millimeters are described as negative ulna or cubitus minus. Zero variant or neutral ulna with ulnar variance or distal radio-ulnar index is between 0-2 mm and cubitus plus when ulnar elongation values greater than 2 mm.
Measured: 22 months
Clinical evaluation preoperative and postoperative: Pain
Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.
Measured: 22 months
Clinical evaluation preoperative and postoperative: Range of motion
Range of motion (ROM): wrist motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) mesure with a goniometer (in degrees).
Measured: 22 months
Secondary outcomes (2)
Radiological variables in the lateral radiograph in the wrist: Palmar Tilt
Palmar tilt (PT) measure in degrees. Palmar tilt is determined by the line drawn across the most distal points of the dorsal and ventral rims of the distal articular surface. The degree of PT is derived by the intersection of the line of PT and a line perpendicular to the long axis of the radius, as seen in the lateral view. The normal limits are 0° to 18°.
Measured: 22 months
Radiological variables in the lateral radiograph in the wrist: Stahl´s Index
Stahl´s index measures the degree of lunate fragmentation and collapse. The normal limits are 0.53+- 0.03. The longitudinal height of the lunate measured on the lateral view is divided by its greatest dorsopalmar dimension. The ratio of these 2 measurements gives the Stahl index.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 May 2024
- Primary completion28 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Kienbock DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460922
- Sponsor's protocol ID
- IIBSP-MPG-2024-04
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Publications
Calfee RP, Van Steyn MO, Gyuricza C, Adams A, Weiland AJ, Gelberman RH. Joint leveling for advanced Kienbock's disease. J Hand Surg Am. 2010 Dec;35(12):1947-54. doi: 10.1016/j.jhsa.2010.08.017. Epub 2010 Oct 25.
PubMed 20971577Horii E, Garcia-Elias M, Bishop AT, Cooney WP, Linscheid RL, Chao EY. Effect on force transmission across the carpus in procedures used to treat Kienbock's disease. J Hand Surg Am. 1990 May;15(3):393-400. doi: 10.1016/0363-5023(90)90049-w.
PubMed 2348055Kennedy C, Abrams R. In Brief: The Lichtman Classification for Kienbock Disease. Clin Orthop Relat Res. 2019 Jun;477(6):1516-1520. doi: 10.1097/CORR.0000000000000595. No abstract available.
PubMed 30507834Lamas C, Mir X, Llusa M, Navarro A. Dorsolateral biplane closing radial osteotomy in zero variant cases of Kienbock's disease. J Hand Surg Am. 2000 Jul;25(4):700-9. doi: 10.1053/jhsu.2000.6929.
PubMed 10913211Lamas C, Carrera A, Proubasta I, Llusa M, Majo J, Mir X. The anatomy and vascularity of the lunate: considerations applied to Kienbock's disease. Chir Main. 2007 Feb;26(1):13-20. doi: 10.1016/j.main.2007.01.001. Epub 2007 Feb 8.
PubMed 17418764Nakamura R, Watanabe K, Tsunoda K, Miura T. Radial osteotomy for Kienbock's disease evaluated by magnetic resonance imaging. 24 cases followed for 1-3 years. Acta Orthop Scand. 1993 Apr;64(2):207-11. doi: 10.3109/17453679308994572.
PubMed 8498188Matsushita K, Firrell JC, Tsai TM. X-ray evaluation of radial shortening for Kienbock's disease. J Hand Surg Am. 1992 May;17(3):450-5. doi: 10.1016/0363-5023(92)90346-q.
PubMed 1613218Miura H, Sugioka Y. Radial closing wedge osteotomy for Kienbock's disease. J Hand Surg Am. 1996 Nov;21(6):1029-34. doi: 10.1016/s0363-5023(96)80311-x.
PubMed 8969427Trumble T, Glisson RR, Seaber AV, Urbaniak JR. A biomechanical comparison of the methods for treating Kienbock's disease. J Hand Surg Am. 1986 Jan;11(1):88-93. doi: 10.1016/s0363-5023(86)80111-3.
PubMed 3944452Tsuge S, Nakamura R. Anatomical risk factors for Kienbock's disease. J Hand Surg Br. 1993 Feb;18(1):70-5. doi: 10.1016/0266-7681(93)90201-p.
PubMed 8436868Soejima O, Iida H, Komine S, Kikuta T, Naito M. Lateral closing wedge osteotomy of the distal radius for advanced stages of Kienbock's disease. J Hand Surg Am. 2002 Jan;27(1):31-6. doi: 10.1053/jhsu.2002.30906.
PubMed 11810611Watanabe K, Nakamura R, Horii E, Miura T. Biomechanical analysis of radial wedge osteotomy for the treatment of Kienbock's disease. J Hand Surg Am. 1993 Jul;18(4):686-90. doi: 10.1016/0363-5023(93)90319-X.
PubMed 8349982Werner FW, Palmer AK. Biomechanical evaluation of operative procedures to treat Kienbock's disease. Hand Clin. 1993 Aug;9(3):431-43.
PubMed 8408253Ma ZJ, Liu ZF, Shi QS, Li T, Liu ZY, Yang ZZ, Liu YH, Xu YJ, Dai K, Yu C, Gan YK, Wang JW. Varisized 3D-Printed Lunate for Kienbock's Disease in Different Stages: Preliminary Results. Orthop Surg. 2020 Jun;12(3):792-801. doi: 10.1111/os.12681. Epub 2020 May 17.
PubMed 32419366
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06460922
- Acronym / sponsor ID
- IIBSP-MPG-2024-04
- Conditions
- Kienbock Disease
- Keywords
- Lunatomalacia, Kienböck´s disease, Radial osteotomy, Biplane radial osteotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The anatomical factors associated with Kienböck´s 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 Kienböck´s 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients affected by lunate necrosis of the wrist, lunatomalacia, or Kienböck´s disease, stages II, IIIA, IIIB or IIIC by Lichtman classification, in which a distal radial osteotomy is indicated.
Key inclusion criteria (1 listed)
- Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial osteotomy3D printing models and personalized guides in surgical planning in distal radius osteotomies for Kienböck´s disease. Osteosynthesis with a plate in distal radius. | Procedure or surgery | – |
Primary outcome
Clinical evaluation preoperative and postoperative: Mayo Wrist Score
Time frame: 22 months
Modified Mayo Wrist Score (MWS). It is based on pain, range of motion, grip strength and function. Scores of 80 to 100 are considered excellent; 65 to 79, good; 50 to 64, moderate; and less than 50, poor.
Disabilities of the arm, shoulder and hand score questionnaire
Time frame: 22 months
Disabilities of the arm, shoulder and hand score (Quick DASH) questionnaire. From 0 (better outcome) to 100% (worse outcome)
Clinical evaluation preoperative and postoperative: Grip strength
Time frame: 22 months
Grip strength mesure with a Jamar dynamometer (in Kilograms).
Radiological variables In the posteroanterior radiographs wrist: Lichtman classification
Time frame: 22 months
Lichtman´s Stage of lunate necrosis classification: 4 stages (1977). Better stage 1, worse stage 4.
Radiological variables In the posteroanterior radiographs wrist: Carpal Ulnar Distance Ratio.
Time frame: 22 months
Carpal Ulnar Distance Ratio (mesure in millimeters) by McMurtry-Youm (1978). Outcomes in a ratio 0.30+-0.03.
Radiological variables In the posteroanterior radiographs wrist. Carpal Height Ratio.
Time frame: 22 months
Carpal Height Ratio (measure in millimeters) by McMurtry-Youm (1978) . Outcomes in a ratio 0.54+-0.03.
Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle.
Time frame: 22 months
The Radial Inclination Angle (RIA) describes the angulation of the distal radial articular surface in relationship with the long axis of the radius or ulna as seen in the posteroanterior view of the wrist. We measure RIA in relationship with the long axis of the ulna. The normal limits are 18.8° to 29.3° (measure in degrees).
Radiological variables In the posteroanterior radiographs wrist: Lunate covering Ratio.
Time frame: 22 months
The Lunate Covering Ratio (LCR) is a measure of the lunate surface protected by the radius, obtained by dividing the width of lunate covered by radius by total lunate width in millimeters x 100.
Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance.
Time frame: 22 months
Ulnar variance was measured as described by Gelberman et al. (1980) The measurement was obtained by projecting a line from the carpal joint surface of the distal end of the radius toward the ulna and measuring the distance in millimeters between this line and the carpal surface of the ulna. Ulnar shortening values of 2 or more millimeters are described as negative ulna or cubitus minus. Zero variant or neutral ulna with ulnar variance or distal radio-ulnar index is between 0-2 mm and cubitus plus when ulnar elongation values greater than 2 mm.
Clinical evaluation preoperative and postoperative: Pain
Time frame: 22 months
Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.
Clinical evaluation preoperative and postoperative: Range of motion
Time frame: 22 months
Range of motion (ROM): wrist motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) mesure with a goniometer (in degrees).
2 secondary outcomes
Radiological variables in the lateral radiograph in the wrist: Palmar Tilt
Time frame: 22 months
Radiological variables in the lateral radiograph in the wrist: Stahl´s Index
Time frame: 22 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 20971577Calfee RP, Van Steyn MO, Gyuricza C, Adams A, Weiland AJ, Gelberman RH. Joint leveling for advanced Kienbock's disease. J Hand Surg Am. 2010 Dec;35(12):1947-54. doi: 10.1016/j.jhsa.2010.08.017. Epub 2010 Oct 25.
- Results publication: PubMed 2348055Horii E, Garcia-Elias M, Bishop AT, Cooney WP, Linscheid RL, Chao EY. Effect on force transmission across the carpus in procedures used to treat Kienbock's disease. J Hand Surg Am. 1990 May;15(3):393-400. doi: 10.1016/0363-5023(90)90049-w.
- Results publication: PubMed 30507834Kennedy C, Abrams R. In Brief: The Lichtman Classification for Kienbock Disease. Clin Orthop Relat Res. 2019 Jun;477(6):1516-1520. doi: 10.1097/CORR.0000000000000595. No abstract available.
- Results publication: PubMed 10913211Lamas C, Mir X, Llusa M, Navarro A. Dorsolateral biplane closing radial osteotomy in zero variant cases of Kienbock's disease. J Hand Surg Am. 2000 Jul;25(4):700-9. doi: 10.1053/jhsu.2000.6929.
- Results publication: PubMed 17418764Lamas C, Carrera A, Proubasta I, Llusa M, Majo J, Mir X. The anatomy and vascularity of the lunate: considerations applied to Kienbock's disease. Chir Main. 2007 Feb;26(1):13-20. doi: 10.1016/j.main.2007.01.001. Epub 2007 Feb 8.
- Results publication: PubMed 8498188Nakamura R, Watanabe K, Tsunoda K, Miura T. Radial osteotomy for Kienbock's disease evaluated by magnetic resonance imaging. 24 cases followed for 1-3 years. Acta Orthop Scand. 1993 Apr;64(2):207-11. doi: 10.3109/17453679308994572.
- Results publication: PubMed 1613218Matsushita K, Firrell JC, Tsai TM. X-ray evaluation of radial shortening for Kienbock's disease. J Hand Surg Am. 1992 May;17(3):450-5. doi: 10.1016/0363-5023(92)90346-q.
- Results publication: PubMed 8969427Miura H, Sugioka Y. Radial closing wedge osteotomy for Kienbock's disease. J Hand Surg Am. 1996 Nov;21(6):1029-34. doi: 10.1016/s0363-5023(96)80311-x.
- Results publication: PubMed 3944452Trumble T, Glisson RR, Seaber AV, Urbaniak JR. A biomechanical comparison of the methods for treating Kienbock's disease. J Hand Surg Am. 1986 Jan;11(1):88-93. doi: 10.1016/s0363-5023(86)80111-3.
- Results publication: PubMed 8436868Tsuge S, Nakamura R. Anatomical risk factors for Kienbock's disease. J Hand Surg Br. 1993 Feb;18(1):70-5. doi: 10.1016/0266-7681(93)90201-p.
- Results publication: PubMed 11810611Soejima O, Iida H, Komine S, Kikuta T, Naito M. Lateral closing wedge osteotomy of the distal radius for advanced stages of Kienbock's disease. J Hand Surg Am. 2002 Jan;27(1):31-6. doi: 10.1053/jhsu.2002.30906.
- Results publication: PubMed 8349982Watanabe K, Nakamura R, Horii E, Miura T. Biomechanical analysis of radial wedge osteotomy for the treatment of Kienbock's disease. J Hand Surg Am. 1993 Jul;18(4):686-90. doi: 10.1016/0363-5023(93)90319-X.
- Individual participant dataSharing planned: No. No plan to share
Related trials for Kienbock Disease
RecruitingObservational study
The KinematX Midcarpal Total Wrist Arthroplasty Registry
Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kienbock Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Lamas, MD, PhD (935537032 ext. 7032, clamasg@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation preoperative and postoperative: Mayo Wrist Score (time frame: 22 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460922, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.