About this trial
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
This trial does not accept healthy volunteersQualifiers
Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Radial osteotomy
Procedure/Surgery3D printing models and personalized guides in surgical planning in distal radius osteotomies for Kienböck´s disease. Osteosynthesis with a plate in distal radius.
Treatment groups
Trial outcomes
Primary outcomes
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.
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)
Clinical evaluation preoperative and postoperative: Grip strength
Grip strength mesure with a Jamar dynamometer (in Kilograms).
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.
Secondary outcomes
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°.
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.
Sponsors and contacts
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