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NCT Number: NCT07614269

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

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.

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Key information

Age range

50 year–88 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Trapezectomy and carpometacarpal joint resection-supension arthroplasty

Procedure

Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.

Other names: trapezium resection ligamentoplasty arthroplasty

Trapeziometacarpal joint prosthesis

Procedure

Joint carpometacarpal prostesis

Other names: Trapeziometacarpal arthroplasty with implant

Primary outcomes

  1. Thumb carpometarcarpal joint radiological evaluation

    Time frame: 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.

  2. Thumb carpometacarpal joint CT scan evaluation

    Time frame: 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.

  3. 3D modeling and finite element methods of evaluation of the CT scan before and after surgical intervention.

    Time frame: 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

Secondary outcomes

  1. Pain pre and postoperative

    Time frame: 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.

  2. Pinch force pre and postoperative

    Time frame: 12 months

    A pinch Jamar dynamometer is used to measure pinch force, scale from 0-30 Kilograms (Sammons Preston, Bolingbrook, IL, USA).

  3. Grip Strength pre and postoperative

    Time frame: 12 months

    A Jamar dynamometer is used to assess grip strength, scale from 0 to 90 Kilograms (Sammons Preston, Bolingbrook, IL, USA).

  4. Range of motion

    Time frame: 12 months

    A goniometer is used to assess the thumb CMC range of motion (flexion, extension, adduction, abduction), measure in grades from 0-90º.

  5. Questionnaire QuickDash

    Time frame: 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).

Study contacts

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

Claudia Lamas, MD, Ph D

CONTACT

[email protected]

00-34-5537032 ext. 7032

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 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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