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Biomechanical Evaluation With Finite Element Models in Thumb Carpometacarpal Osteoarthitis: Prospective Comparative Analysis of Loads in Arthroplasty With or Without Implants

25 de maio de 2026 atualizado por: Claudia Lamas, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
To better understand the load distribution in the Thumb Carpometacarpal Joint (CMC joint) in presence of osteoarthritis and how surgery by means of a suspension-resection arthroplasty or a joint replacement by means of a metal prosthesis affects this load distribution. These studies allow to supporting medical decisions and surgical treatments results with biomechanical evidence.The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process.

Visão geral do estudo

Descrição detalhada

For determine the normal kinematics of the thumb carpometacarpal (CMC) joint, Imaeda et al. (1994) examined in specimens four conditions which simulated normal function of the thumb: a) passive circumduction, b) active circumduction, c) static loading, and d) single-axis loading. Changes in normal kinematics predispose the CMC joint to osteoarthritis (OA). Previous studies used radiographic techniques that usually were static or measured the end range of motion.

For thumb CMC joint OA the prosthesis or total joint arthroplasty is one of the surgical option. Murai (2022) studied in ten healthy men with reconstruction 3D bone models the optimal center of rotation of the implant and found that the center of rotation change across various thumb positions. In the study by D´Agostino et al. (2018) a CT scan was used to quantify the 3D thumb kinematics in four female patients, before and after trapeziometacarpal joint replacement surgery with the Arpe implant. Thumb CMC joint OA led to a marked decrease of internal rotation and abduction of the first metacarpal during thumb flexion and a decrease of metacarpal adduction during thumb adduction. The abcense of first metacarpal translation in the ball-and-socket implant seems to indicate a decrease of first metacarpal adduction. Advanced thumb CMC joint OA mainly restrict the first metacarpal mobility. Whereas prosthesis is able to restore thumb function, it cannot fully replicate the kinematics of the healthy trapeziometacarpal joint.

This study will include 40 adults patients with chronic pain and carpometacarpal osteoarthritis that need surgical intervention. For the biomechanical evaluation, 3D modeling and finite element methods of evaluation of the CT scan before and after the surgical intervention in each patient will be performed with the computed specific software Epylisis and Ansys in Dimension Lab 3D, Hospital de la Santa Creu i Sant Pau by biomedical engineers.

The source of information is the journals and journals specialized in hand surgery, bioengineering, biotechnology and biomedical engineering.

The principal investigator and collaborators are responsible for creating the database and entering data. Statistical analysis requires support from the statistics unit of the UICEC/Hospital de la Santa Creu i Sant Pau. All data will be collected in REDCap.

Tipo de estudo

Observacional

Inscrição (Estimado)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Claudia Lamas, MD, Ph D
  • Número de telefone: 7032 00-34-5537032
  • E-mail: clamasg@santpau.cat

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

Adult patients with chronic pain and thumb CMC joint osteoarthritis that need surgical treatment.

Descrição

Inclusion Criteria:

  • Primary Osteoarthritis in thumb CMC joint in the hand
  • Adults aged between 50 and 88 years old included.
  • Thumb CMC joint osteoarthritis, radiographic stages II, III and IV by Eaton- Littler classification (1973).

Exclusion Criteria:

  • Asymptomatic primary osteoarthritis in thumb CMC joint
  • Patients with osteoarthritis and age less than 50 years or more than 88 years.
  • Patients who have had previous interventions in the area, in this joint, injuries in this hand or fractures.
  • Patients with rheumatic diseases or collagen diseases that create joint instability.
  • Patients with physical or mental conditions that preclude intervention.
  • Thumb CMC joint osteoarthritis, radiographic stages I by Eaton-Littler classification (1973)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Suspension-resection arthroplasty

This is a usual surgical treatment for patients with chronic pain and thumb CMC joint osteoarthritis. The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process.

Procedure performe with a suspension-resection arthroplasty by modified Welby´s technique. Dorso-lateral approach. Complete resection of the trapezium and joint stabilization with tendon interposition arthroplasty. After resection a distally based strip of the Abductor Pollicis Longus tendon is looped along the Flexor Carpi Radialis tendon. After surgical intervention the immobilization is one month with a plaster cast.

Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.
Outros nomes:
  • trapezium resection ligamentoplasty arthroplasty
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Trapeziometacarpal joint prosthesis

This is a usual surgical treatment for patients with chronic pain and thumb CMC joint osteoarthritis. The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process.

Procedure performe with a thumb CMC joint prosthesis. Dorso-lateral approach. Insertion of a dual mobility trapeziometacarpal joint prosthesis. The Prosthesis consists of a hemispherical cup, a modular neck and of an anatomical metacarpal stem. It offers a complete range of implants allowing the choice between single and double mobility. After surgical intervention the immobilization is one month with a plaster cast.

Joint carpometacarpal prostesis
Outros nomes:
  • Trapeziometacarpal arthroplasty with implant

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Thumb carpometarcarpal joint radiological evaluation
Prazo: 12 months
Standard radiographs are required x-rays in posteroanterior (PA), PA in pronation (Robert´s view) and lateral views for assessment of the radiological stages of Eaton-Littler modified by Eaton-Glicker classification (1973). This classification include four stages of progression of the loss cartilage in thumb CMC joint, from I to IV. The X-rays will made in clinics at 6 weeks, 3 months, 6 months and 12 months after the surgical repair.
12 months
Thumb carpometacarpal joint CT scan evaluation
Prazo: 12 months
A Computed Tomography (CT) scan is also required for the initial evaluation and regular control of these patients. For each participant, CT scans will be perform in static limb positions before and after the surgery.
12 months
3D modeling and finite element methods of evaluation of the CT scan before and after surgical intervention.
Prazo: 12 months

In each patient will be performed with the computed specific software Epylisis and Ansys in Dimension Lab 3D, Hospital de la Santa Creu i Sant Pau by biomedical engineers.

To obtain the 3D geometrical information for a subject-specific finite element human hand, CT images will take from patients. Each scan is recontructed in a Digital Imaging and Communications in Medicine (DICOM) format. These 2D data (DICOM data collection) are process using medical image processing software Mimics (Materialise, Leuven, Belgium). All the CT images will be segmented manually into the bones and skin, while subcutaneous tissues and tendons will be reconstructed based on CT images.

A specific software (Epylisis, Ansys) will be used to simulated the loads in the thumb CMC joint. Epylisis is one of this specific software based on the Finite Element Methods (FEM), enables computational simulation of the biomechanical behavior of the trapeziometacarpal joint. It is used to conduct mechanistic analyses

12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pain pre and postoperative
Prazo: 12 months
A Visual Analoge Scale (VAS) is used to assess pain (range, 0-10). This scale is from 0, no pain to 10, uncontrollable pain.
12 months
Pinch force pre and postoperative
Prazo: 12 months
A pinch Jamar dynamometer is used to measure pinch force, scale from 0-30 Kilograms (Sammons Preston, Bolingbrook, IL, USA).
12 months
Grip Strength pre and postoperative
Prazo: 12 months
A Jamar dynamometer is used to assess grip strength, scale from 0 to 90 Kilograms (Sammons Preston, Bolingbrook, IL, USA).
12 months
Range of motion
Prazo: 12 months
A goniometer is used to assess the thumb CMC range of motion (flexion, extension, adduction, abduction), measure in grades from 0-90º.
12 months
Questionnaire QuickDash
Prazo: 12 months
The clinical and functional outcomes is evaluate using the Questionnaire QuickDash, Disabilities of the Arm, Shoulder and Hand, consist of 30 items (11 items, scored 1-5). The QuickDASH score ranges from 0 (no disability) to 100 (most severe disability).
12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

25 de novembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

15 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de maio de 2026

Primeira postagem (Real)

29 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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