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

May 25, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Trapezectomy and carpometacarpal joint resection-supension arthroplasty
Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.
Other Names:
  • 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.
Procedure: Trapeziometacarpal joint prosthesis
Joint carpometacarpal prostesis
Other Names:
  • Trapeziometacarpal arthroplasty with implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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).
12 months
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).
12 months
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.
12 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-BIE-2025-145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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