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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radial osteotomy

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
22 months
2

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)

Time frame
22 months
3

Clinical evaluation preoperative and postoperative: Grip strength

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

Time frame
22 months
4

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.

Time frame
22 months

Secondary outcomes

1

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°.

Time frame
22 months
2

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.

Time frame
22 months

Other outcomes

Sponsors and contacts

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