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

NCT07614269 | Not Yet Recruiting

• 1 other identifier: IIBSP-BIE-2025-145
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thumb Carpometacarpal Joint Osteoarthritis

Keywords

Thumb carpometacarpal joint osteoarthritis; carpometacarpal prosthesis; Thumb carpometacarpal arthroplasty

Outcome Measures

Primary Outcomes (3)

• Thumb carpometarcarpal joint radiological evaluation

  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

  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.

  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 Outcomes (5)

• Pain pre and postoperative

  12 months

• Pinch force pre and postoperative

  12 months

• Grip Strength pre and postoperative

  12 months

• Range of motion

  12 months

• Questionnaire QuickDash

  12 months

Study Arms (2)

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

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

Interventions

Trapezectomy and carpometacarpal joint resection-supension arthroplasty PROCEDURE

Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.

Also known as: trapezium resection ligamentoplasty arthroplasty

Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Suspension-resection arthroplasty

Trapeziometacarpal joint prosthesis PROCEDURE

Joint carpometacarpal prostesis

Also known as: Trapeziometacarpal arthroplasty with implant

Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Trapeziometacarpal joint prosthesis

Eligibility Criteria

• Age: 50 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Related Publications (10)

• van Cappelle HG, Elzenga P, van Horn JR. Long-term results and loosening analysis of de la Caffiniere replacements of the trapeziometacarpal joint. J Hand Surg Am. 1999 May;24(3):476-82. doi: 10.1053/jhsu.1999.0476.

  PMID: 10357524 BACKGROUND

• Imaeda T, Cooney WP, Niebur GL, Linscheid RL, An KN. Kinematics of the trapeziometacarpal joint: a biomechanical analysis comparing tendon interposition arthroplasty and total-joint arthroplasty. J Hand Surg Am. 1996 Jul;21(4):544-53. doi: 10.1016/S0363-5023(96)80002-5.

  PMID: 8842942 BACKGROUND

• Vermeulen GM, Brink SM, Sluiter J, Elias SG, Hovius SE, Moojen TM. Ligament reconstruction arthroplasty for primary thumb carpometacarpal osteoarthritis (weilby technique): prospective cohort study. J Hand Surg Am. 2009 Oct;34(8):1393-401. doi: 10.1016/j.jhsa.2009.06.019. Epub 2009 Sep 6.

  PMID: 19733982 RESULT

• Vadstrup LS, Schou L, Boeckstyns ME. Basal joint osteoarthritis of the thumb treated with Weilby arthroplasty: a prospective study on the early postoperative course of 106 consecutive cases. J Hand Surg Eur Vol. 2009 Aug;34(4):503-5. doi: 10.1177/1753193409105084. Epub 2009 Jul 8.

  PMID: 19587074 RESULT

• Spartacus V, Mayoly A, Gay A, Le Corroller T, Nemoz-Gaillard M, Roffino S, Chabrand P. Biomechanical causes of trapeziometacarpal arthroplasty failure. Comput Methods Biomech Biomed Engin. 2017 Aug;20(11):1233-1235. doi: 10.1080/10255842.2017.1348502. Epub 2017 Jul 4.

  PMID: 28675048 RESULT

• Murai A, Kurosawa A, Tada K, Tachiya H, Tamai A, Akahane M, Matsuta M, Nakamura Y, Kawashima H, Tsuchiya H. Optimal Center of Rotation for Ball-And-Socket Thumb Carpometacarpal Arthroplasty Identified Using Three-Dimensional Kinematic Analysis: A Pilot Study. Front Bioeng Biotechnol. 2022 Jun 1;10:868150. doi: 10.3389/fbioe.2022.868150. eCollection 2022.

  PMID: 35721848 RESULT

• Kerkhof FD, Schneider MTY, Shelby T, Weiss AC, Moore DC, Crisco JJ, Ladd AL. Morphological changes to peripheral joints supporting thumb trapezial metacarpal osteoarthritis. J Biomech. 2025 Feb;180:112519. doi: 10.1016/j.jbiomech.2025.112519. Epub 2025 Jan 7.

  PMID: 39826288 RESULT

• Hansen TB, Stilling M. Equally good fixation of cemented and uncemented cups in total trapeziometacarpal joint prostheses. A randomized clinical RSA study with 2-year follow-up. Acta Orthop. 2013 Feb;84(1):98-105. doi: 10.3109/17453674.2013.765625. Epub 2013 Jan 23.

  PMID: 23343372 RESULT

• Dong M, Kerkhof F, Deleu G, Vereecke E, Ladd A. Using a finite element model of the thumb to study Trapeziometacarpal joint contact during lateral pinch. Clin Biomech (Bristol). 2023 Jan;101:105852. doi: 10.1016/j.clinbiomech.2022.105852. Epub 2022 Dec 5.

  PMID: 36521409 RESULT

• D'Agostino P, Dourthe B, Kerkhof F, Vereecke EE, Stockmans F. Impact of Osteoarthritis and Total Joint Arthroplasty on the Kinematics of the Trapeziometacarpal Joint: A Pilot Study. J Hand Surg Am. 2018 Apr;43(4):382.e1-382.e10. doi: 10.1016/j.jhsa.2017.10.011. Epub 2017 Nov 14.

  PMID: 29146507 RESULT

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Claudia Lamas, MD, Ph D

CONTACT

00-34-5537032; clamasg@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hand Unit and Upper Limb. Department of Orthopaedic Surgery. Hospital de la Santa Creu i Sant Pau. Universitat Autonoma de Barcelona. IP Musculoskeletal Group Institut de Recerca

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share