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NCT Number: NCT06460922

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location status: Recruiting

Location contact

Claudia Delgado, MD

CONTACT

[email protected]

+34935537634

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinical evaluation preoperative and postoperative: Mayo Wrist Score

    Time frame: 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.

  2. Disabilities of the arm, shoulder and hand score questionnaire

    Time frame: 22 months

    Disabilities of the arm, shoulder and hand score (Quick DASH) questionnaire. From 0 (better outcome) to 100% (worse outcome)

  3. Clinical evaluation preoperative and postoperative: Grip strength

    Time frame: 22 months

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

  4. Radiological variables In the posteroanterior radiographs wrist: Lichtman classification

    Time frame: 22 months

    Lichtman´s Stage of lunate necrosis classification: 4 stages (1977). Better stage 1, worse stage 4.

  5. Radiological variables In the posteroanterior radiographs wrist: Carpal Ulnar Distance Ratio.

    Time frame: 22 months

    Carpal Ulnar Distance Ratio (mesure in millimeters) by McMurtry-Youm (1978). Outcomes in a ratio 0.30+-0.03.

  6. Radiological variables In the posteroanterior radiographs wrist. Carpal Height Ratio.

    Time frame: 22 months

    Carpal Height Ratio (measure in millimeters) by McMurtry-Youm (1978) . Outcomes in a ratio 0.54+-0.03.

  7. Radiological variables In the posteroanterior radiographs wrist: Radial Inclination Angle.

    Time frame: 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).

  8. Radiological variables In the posteroanterior radiographs wrist: Lunate covering Ratio.

    Time frame: 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.

  9. Radiological variables In the posteroanterior radiographs wrist. Ulnar Variance.

    Time frame: 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.

  10. Clinical evaluation preoperative and postoperative: Pain

    Time frame: 22 months

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

  11. Clinical evaluation preoperative and postoperative: Range of motion

    Time frame: 22 months

    Range of motion (ROM): wrist motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination) mesure with a goniometer (in degrees).

Secondary outcomes

  1. Radiological variables in the lateral radiograph in the wrist: Palmar Tilt

    Time frame: 22 months

    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°.

  2. Radiological variables in the lateral radiograph in the wrist: Stahl´s Index

    Time frame: 22 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra Guerrero-Espinosa, MD, Ph D

CONTACT

[email protected]

935537796 ext. 7796

Claudia Lamas, MD, PhD

CONTACT

[email protected]

935537032 ext. 7032

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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