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

Kienbock Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460922
• Other study ID #: IIBSP-MPG-2024-04
• Status: Recruiting
• Start date: May 10, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Claudia Lamas, MD, PhD
• Phone: 935537032
• Email: clamasg[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Kienbock´s disease in the wrist estages II, IIIA, IIIB or IIIC by Lichtman classification

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Kienbock Disease
• Osteonecrosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Calfee RP, Van Steyn MO, Gyuricza C, Adams A, Weiland AJ, Gelberman RH. Joint leveling for advanced Kienbock's disease. J Hand Surg Am. 2010 Dec;35(12):1947-54. doi: 10.1016/j.jhsa.2010.08.017. Epub 2010 Oct 25. — View Citation

Horii E, Garcia-Elias M, Bishop AT, Cooney WP, Linscheid RL, Chao EY. Effect on force transmission across the carpus in procedures used to treat Kienbock's disease. J Hand Surg Am. 1990 May;15(3):393-400. doi: 10.1016/0363-5023(90)90049-w. — View Citation

Kennedy C, Abrams R. In Brief: The Lichtman Classification for Kienbock Disease. Clin Orthop Relat Res. 2019 Jun;477(6):1516-1520. doi: 10.1097/CORR.0000000000000595. No abstract available. — View Citation

Lamas C, Carrera A, Proubasta I, Llusa M, Majo J, Mir X. The anatomy and vascularity of the lunate: considerations applied to Kienbock's disease. Chir Main. 2007 Feb;26(1):13-20. doi: 10.1016/j.main.2007.01.001. Epub 2007 Feb 8. — View Citation

Lamas C, Mir X, Llusa M, Navarro A. Dorsolateral biplane closing radial osteotomy in zero variant cases of Kienbock's disease. J Hand Surg Am. 2000 Jul;25(4):700-9. doi: 10.1053/jhsu.2000.6929. — View Citation

Ma ZJ, Liu ZF, Shi QS, Li T, Liu ZY, Yang ZZ, Liu YH, Xu YJ, Dai K, Yu C, Gan YK, Wang JW. Varisized 3D-Printed Lunate for Kienbock's Disease in Different Stages: Preliminary Results. Orthop Surg. 2020 Jun;12(3):792-801. doi: 10.1111/os.12681. Epub 2020 M — View Citation

Matsushita K, Firrell JC, Tsai TM. X-ray evaluation of radial shortening for Kienbock's disease. J Hand Surg Am. 1992 May;17(3):450-5. doi: 10.1016/0363-5023(92)90346-q. — View Citation

Miura H, Sugioka Y. Radial closing wedge osteotomy for Kienbock's disease. J Hand Surg Am. 1996 Nov;21(6):1029-34. doi: 10.1016/s0363-5023(96)80311-x. — View Citation

Nakamura R, Watanabe K, Tsunoda K, Miura T. Radial osteotomy for Kienbock's disease evaluated by magnetic resonance imaging. 24 cases followed for 1-3 years. Acta Orthop Scand. 1993 Apr;64(2):207-11. doi: 10.3109/17453679308994572. — View Citation

Soejima O, Iida H, Komine S, Kikuta T, Naito M. Lateral closing wedge osteotomy of the distal radius for advanced stages of Kienbock's disease. J Hand Surg Am. 2002 Jan;27(1):31-6. doi: 10.1053/jhsu.2002.30906. — View Citation

Trumble T, Glisson RR, Seaber AV, Urbaniak JR. A biomechanical comparison of the methods for treating Kienbock's disease. J Hand Surg Am. 1986 Jan;11(1):88-93. doi: 10.1016/s0363-5023(86)80111-3. — View Citation

Tsuge S, Nakamura R. Anatomical risk factors for Kienbock's disease. J Hand Surg Br. 1993 Feb;18(1):70-5. doi: 10.1016/0266-7681(93)90201-p. — View Citation

Watanabe K, Nakamura R, Horii E, Miura T. Biomechanical analysis of radial wedge osteotomy for the treatment of Kienbock's disease. J Hand Surg Am. 1993 Jul;18(4):686-90. doi: 10.1016/0363-5023(93)90319-X. — View Citation

Werner FW, Palmer AK. Biomechanical evaluation of operative procedures to treat Kienbock's disease. Hand Clin. 1993 Aug;9(3):431-43. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinical evaluation preoperative and postoperative: Grip strength	Grip strength mesure with a Jamar dynamometer (in Kilograms).	22 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Clinical evaluation preoperative and postoperative: Pain	Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.	22 months
Primary	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	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
Secondary	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