Clinical trial NCT06460922: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kienbock Disease
Keywords: Lunatomalacia
Kienböck´s disease
Radial osteotomy
Biplane radial osteotomy
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Clinical evaluation preoperative and postoperative: Mayo Wrist Score
timeFrame: 22 months
measure: Disabilities of the arm, shoulder and hand score questionnaire
timeFrame: 22 months
measure: Clinical evaluation preoperative and postoperative: Grip strength
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist: Lichtman classification
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist: Carpal Ulnar Distance Ratio.
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist. Carpal Height Ratio.
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle.
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist: Lunate covering Ratio.
timeFrame: 22 months
measure: Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance.
timeFrame: 22 months
measure: Clinical evaluation preoperative and postoperative: Pain
timeFrame: 22 months
measure: Clinical evaluation preoperative and postoperative: Range of motion
timeFrame: 22 months
Secondary outcomes:
measure: Radiological variables in the lateral radiograph in the wrist: Palmar Tilt
timeFrame: 22 months
measure: Radiological variables in the lateral radiograph in the wrist: Stahl´s Index
timeFrame: 22 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Research Institute IIB Sant Pau. Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau
name: Claudia Lamas, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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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 May 17.