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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-88
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Trapezectomy and carpometacarpal joint resection-supension arthroplasty

    Procedure/Surgery

    Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.

  • Trapeziometacarpal joint prosthesis

    Procedure/Surgery

    Joint carpometacarpal prostesis

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Suspension-resection arthroplasty1 intervention
Group B: Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Trapeziometacarpal joint prosthesis1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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

Time frame
12 months

Secondary outcomes

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.

Time frame
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).

Time frame
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).

Time frame
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.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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