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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical evaluation preoperative and postoperative: Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification
排除标准
- •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
结局指标
主要结局
Clinical evaluation preoperative and postoperative: Pain
时间窗: 22 months
Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.
Disabilities of the arm, shoulder and hand score questionnaire
时间窗: 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
时间窗: 22 months
Grip strength mesure with a Jamar dynamometer (in Kilograms).
Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle.
时间窗: 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).
Clinical evaluation preoperative and postoperative: Range of motion
时间窗: 22 months
Range of motion (ROM): wrist motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) mesure with a goniometer (in degrees).
Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance.
时间窗: 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: Mayo Wrist Score
时间窗: 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.
Radiological variables In the posteroanterior radiographs wrist: Lichtman classification
时间窗: 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 Height Ratio.
时间窗: 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: Carpal Ulnar Distance Ratio.
时间窗: 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: Lunate covering Ratio.
时间窗: 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.
次要结局
- Radiological variables in the lateral radiograph in the wrist: Palmar Tilt(22 months)
- Radiological variables in the lateral radiograph in the wrist: Stahl´s Index(22 months)