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

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.

Overview

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.

Detailed 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.

Interventions

• 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.

Primary outcome measures

• Clinical evaluation preoperative and postoperative: Mayo Wrist Score [Time frame: 22 months]
• Disabilities of the arm, shoulder and hand score questionnaire [Time frame: 22 months]
• Clinical evaluation preoperative and postoperative: Grip strength [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist: Lichtman classification [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist: Carpal Ulnar Distance Ratio. [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist. Carpal Height Ratio. [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle. [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist: Lunate covering Ratio. [Time frame: 22 months]
• Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance. [Time frame: 22 months]
• Clinical evaluation preoperative and postoperative: Pain [Time frame: 22 months]

Secondary outcome measures (2)

• Radiological variables in the lateral radiograph in the wrist: Palmar Tilt [Time frame: 22 months]
• Radiological variables in the lateral radiograph in the wrist: Stahl´s Index [Time frame: 22 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Hospital de la Santa Creu i Sant Pau — Barcelona

Publications

• 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. PMID 20971577
• 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. PMID 2348055
• 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. PMID 30507834
• 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. PMID 10913211
• 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. PMID 17418764
• 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. PMID 8498188
• 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. PMID 1613218
• 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. PMID 8969427

Identifiers

NCT: NCT06460922 · IIBSP-MPG-2024-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗