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

Condition(s) studied

Investigational drug(s) / intervention(s)

Radial osteotomy: 3D printing models and personalized guides in surgical planning in distal radius osteotomies for Kienböck´s disease. Osteosynthesis with a plate in distal radius.

Study 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

Primary outcome measure(s)

• Clinical evaluation preoperative and postoperative: Mayo Wrist Score — 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 — 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 — 22 months
  Grip strength mesure with a Jamar dynamometer (in Kilograms).
• Radiological variables In the posteroanterior radiographs wrist: Lichtman classification — 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. — 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. — 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. — 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. — 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. — 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 — 22 months
  Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.
• Clinical evaluation preoperative and postoperative: Range of motion — 22 months
  Range of motion (ROM): wrist motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) mesure with a goniometer (in degrees).

Trial sites (1)

More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain