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

NCT06460922 | Recruiting

• 1 other identifier: IIBSP-MPG-2024-04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kienbock Disease

Keywords

Lunatomalacia; Kienböck´s disease; Radial osteotomy; Biplane radial osteotomy

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• Clinical evaluation preoperative and postoperative: Grip strength

  Grip strength mesure with a Jamar dynamometer (in Kilograms).

  22 months

• 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

• 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

• 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

• 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

• 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

• 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

• Clinical evaluation preoperative and postoperative: Pain

  Visual Analog Score, from 0 to 10. Better outcome 0 and worse 10.

  22 months

• 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 Outcomes (2)

• 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

Interventions

Radial osteotomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related 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.

  PMID: 20971577 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 3944452 RESULT

• 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.

  PMID: 8436868 RESULT

• 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.

  PMID: 11810611 RESULT

• 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.

  PMID: 8349982 RESULT

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

  PMID: 8408253 RESULT

• 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 May 17.

  PMID: 32419366 RESULT

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Lamas, MD, Ph D

  Research Institute IIB Sant Pau. Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Lamas, MD, PhD

CONTACT

935537032; clamasg@santpau.cat

Alejandra Guerrero-Espinosa, MD, Ph D

CONTACT

935537796; AespinosaG@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 14, 2024
• Study Start: May 10, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)