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Thumb Carpometacarpal Joint OsteoarthritisNCT07614269

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

An observational study of Thumb Carpometacarpal Joint Osteoarthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 88 years
What is being tested?
Trapezectomy and carpometacarpal joint resection-supension arthroplasty and Trapeziometacarpal joint prosthesis
Type of treatment
Surgery or procedure
How many people
40 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 31 Dec 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Claudia Lamas, MD, Ph D contact

00-34-5537032 ext. 7032

clamasg@santpau.cat

About this study

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.

Read the 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.

Being tested
Trapezectomy and carpometacarpal joint resection-supension arthroplasty, Trapeziometacarpal joint prosthesis
Keywords
Thumb carpometacarpal joint osteoarthritis, carpometacarpal prosthesis, Thumb carpometacarpal arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trapezectomy and carpometacarpal joint resection-supension arthroplastyProcedure or surgery

    Also called trapezium resection ligamentoplasty arthroplasty

    Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.

  • Trapeziometacarpal joint prosthesisProcedure or surgery

    Also called Trapeziometacarpal arthroplasty with implant

    Joint carpometacarpal prostesis

Study groups in NCT07614269
Study groupRoleWhat they receive
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Suspension-resection arthroplastyThis 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.
Receives: Procedure: Trapezectomy and carpometacarpal joint resection-supension arthroplasty
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Trapeziometacarpal joint prosthesisThis 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.
Receives: Procedure: Trapeziometacarpal joint prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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

    Measured: 12 months

Secondary outcomes (5)
  1. Pain pre and postoperative

    A Visual Analoge Scale (VAS) is used to assess pain (range, 0-10). This scale is from 0, no pain to 10, uncontrollable pain.

    Measured: 12 months

  2. Pinch force pre and postoperative

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

    Measured: 12 months

  3. Grip Strength pre and postoperative

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

    Measured: 12 months

  4. Range of motion

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

    Measured: 12 months

  5. Questionnaire QuickDash

    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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion25 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614269
Sponsor's protocol ID
IIBSP-BIE-2025-145
Status last verified
May 2026
First submitted
15 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10357524
  • 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.

    PubMed 8842942
  • 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.

    PubMed 19733982
  • 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.

    PubMed 19587074
  • 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.

    PubMed 28675048
  • 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.

    PubMed 35721848
  • 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.

    PubMed 39826288
  • 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.

    PubMed 23343372
  • 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.

    PubMed 36521409
  • 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.

    PubMed 29146507

Questions about this trial

What is this clinical trial studying?

An observational study of Thumb Carpometacarpal Joint Osteoarthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudia Lamas, MD, Ph D (00-34-5537032 ext. 7032, clamasg@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thumb carpometarcarpal joint radiological evaluation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07614269, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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