3D Printing Models in Surgical Planning of Osteotomies in Kienbock´s Disease Stages II-III
NCT Number: NCT06460922
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kienbock Disease
Interventions: PROCEDURE: Radial osteotomy
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2026-03-31
Locations: Hospital de la Santa Creu i Sant Pau, Barcelona, 08041, Spain

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.

Primary Outcome Measures: 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., 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), 22 months|Clinical evaluation preoperative and postoperative: Grip strength, Grip strength mesure with a Jamar dynamometer (in Kilograms)., 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., 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., 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., 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)., 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., 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., 22 months|Clinical evaluation preoperative and postoperative: Pain, Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10., 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)., 22 months
Secondary Outcome Measures: 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°., 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., 22 months