An observational study in Thumb Carpometacarpal Joint Osteoarthritis, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Not yet recruiting. Open to participants aged 50 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 601 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
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Adult patients with chronic pain and thumb CMC joint osteoarthritis that need surgical treatment.
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Exclusion Criteria:
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
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
Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.
Also known as: trapezium resection ligamentoplasty arthroplasty
Joint carpometacarpal prostesis
Also known as: Trapeziometacarpal arthroplasty with implant
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
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
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
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
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
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
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
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).
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2026; primary completion for Nov 2026, 5 months later.
Of 146 non-industry observational studies under Osteoarthritis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 97. This study's planned 5 months is below that.
Counting every sponsor, half of 228 studies reached it within 57 months; a quarter within 21 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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