An observational study in Kienbock Disease, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 20 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
3D printing models and personalized guides in surgical planning in distal radius osteotomies for Kienböck´s disease. Osteosynthesis with a plate in distal radius.
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.
Time frame: 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)
Time frame: 22 months
Clinical evaluation preoperative and postoperative: Grip strength
Grip strength mesure with a Jamar dynamometer (in Kilograms).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 22 months
Clinical evaluation preoperative and postoperative: Pain
Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.
Time frame: 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).
Time frame: 22 months
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°.
Time frame: 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.
Time frame: 22 months
Plan to share: No — No plan to share
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau →