Clinical Research Directory

ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

Trapeziometacarpal osteoarthritis (TMC OA) is a common condition affecting the base of the thumb that causes pain, weakness, and difficulty with daily hand use. Current clinical assessment often focuses on physical findings alone, without considering psychological and social factors that also influence patient outcomes. This study has three objectives organized as interrelated work packages: OBJECTIVE 1 (Clinical Assessment): To comprehensively assess individuals with TMC OA using the International Classification of Functioning, Disability and Health (ICF) framework. This includes evaluating pain, joint mobility, grip strength, daily activity limitations, social participation, psychological factors (anxiety, depression, fear of movement, pain beliefs), and environmental factors (family support, ergonomic adaptations). OBJECTIVE 2 (AI Knowledge Evaluation): To compare the medical knowledge performance of four large language models (Claude, ChatGPT, Gemini, LLaMA) in answering clinical questions about TMC OA, using criteria such as accuracy, reproducibility, comprehensiveness, clinical relevance, and readability. OBJECTIVE 3 (AI-Based Prediction): To analyze whether the best-performing large language model can predict multidimensional ICF-based patient profiles using only a limited set of core clinical parameters.

Thumb Proprioception in Trapeziometacarpal Osteoarthritis

This study looks at people who have osteoarthritis at the base of the thumb. It examines how well the thumb can sense its position and movement. The study has three goals: 1. To compare these measurements between people with thumb base osteoarthritis and healthy people. 2. To find out whether this ability changes from milder to more advanced levels of osteoarthritis. 3. To explore whether this ability is related to factors such as basic personal characteristics, thumb/hand muscle strength and hand use, pain and touch sensation, and emotional factors like fear of movement, anxiety, and depression. This is an observational study. No treatment is given. Participants complete thumb measurements and several tests/questionnaires.

Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis

The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis. The main question this study aims to address is : \- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function. Participant will: * Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0 * Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.

Thumb Muscle Activation During First Dorsal Interosseous Exercise in Thumb Base Osteoarthritis

The aim of this study is to investigate whether there are differences in muscle activation of the First Dorsal Interosseous (FDI) and the Abductor Pollicis Longus (APL) between individuals with and without trapeziometacarpal osteoarthritis (TMC OA) of the thumb. The study also seeks to identify which exercises are most effective for activating these muscles, in order to inform rehabilitation strategies for patients. The FDI has been defined as a key stabilizer of the thumb TMC joint. However, the literature reports various protocols for FDI activation and limited information on APL behavior during these exercises. OA TMC of the thumb can cause pain, decreased thumb strength, impaired hand function, and difficulty performing activities of daily living (ADLs). Appropriate rehabilitation is essential to maintain muscle function, limit joint degeneration, and improve hand performance; however, the exercises that optimally activate the FDI and APL muscles are not yet established. Participants will perform a series of standardized exercises and functional tasks designed to activate the FDI and APL muscles. Exercises include FDI strengthening with elastic bands in different hand positions (palmar and ulnar support), as well as exercises with the thumb in greater abduction. Functional tasks simulating everyday activities (e.g., turning a key, picking up a coin, writing, squeezing a tube of toothpaste, and holding a glass of water) will also be performed. Muscle activity will be recorded using surface electromyography (sEMG) during all tasks. Adults aged 40 years and older, both men and women, with TMC osteoarthritis and healthy controls without osteoarthritis will be invited to participate. Researchers will measure the activation patterns of the FDI and APL muscles during the exercises and functional tasks. The study aims to identify exercises that optimally activate these muscles, providing evidence to guide the rehabilitation of patients with thumb base osteoarthritis.

Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)

Thumb osteoarthritis or trapeziometacarpal osteoarthritis (TMO) is a common and painful form of hand arthritis that limits thumb mobility and hand function, affecting patients' quality of life. Although corticosteroids injections are a typical treatment, their effectiveness has been challenged, and side effects have been reported. Recent studies suggest that saline injections, usually considered inactive, might be a viable treatment option. The primary goal of this study is to compare the effectiveness of saline injections versus corticosteroids injections in reducing TMO-related pain and improving hand function. In this study, 40 people with TMO will be randomly assigned to receive either a corticosteroids or a saline injection, without them or the doctors performing the injection knowing which one was administered (double blind). If saline injections prove more effective, they could provide a less harmful and cheaper therapeutic alternative for TMO patients.

Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms. The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively. The study design is a follow-up study of a multicenter cohort.

Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS

Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments. Growing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the treatment of osteoarthritis in various body districts with the intention of limiting joint hypermobility, stabilizing the structure of joint and peri-articular components, reducing pain, and consequently improving function. Several clinical studies have demonstrated that its intra-articular infiltrative use could result in pain reduction and improvement of functionality in various cases of gonarthrosis and coxarthrosis. Regarding the conservative management of symptomatic thumb base osteoarthritis, some studies, albeit on limited case series, have highlighted how the use of type I collagen at the joint and peri-articular level can lead to better control of painful symptoms, improvement in functionality, and reduction of joint instability. Recently, Randelli F. et al. studied the in vitro effects on tenocytes induced by type I swine collagen (MD-Tissue Collagen Medical Device). In vitro results seem to demonstrate that this medical device can induce proliferation and migration of tenocytes and synthesis, maturation, and secretion of type I collagen, favoring tendon repair. Randelli F. et al. also demonstrated the mainly mechanical activity of MD-Tissue Collagen Medical Device, which is able to induce modifications of morpho-functional properties of tenocytes. In this Clinical Investigation, we aim to investigate the performance and safety of an injectable medical device based on type I collagen of swine origin called MD-Small Joints Collagen Medical Device, in the treatment of symptomatic thumb base osteoarthritis. The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis. The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis, at time T6 weeks (T6w) compared to T0 (day0). A reduction of at least 30% in the VAS score is considered clinically significant. Secondary endpoints will consist of evaluating the performance of MD-Small Joints Collagen Medical Device through: * VAS score assessment at T3 week and T16week /FU compared to T0; * Disability of the Arm Shoulder and Hand score assessment at T6 week and T16 week /FU compared to T0 (day0); * Functional Index for Hand Osteoarthritis assessment at T6 week and T16 week /FU compared to T0; * Pinch Strength Test assessment at T6 week and T16 week/FU compared to T0; * Evaluation of analgesic drug consumption through clinical diary in various study phases; * Assessment of Adverse Event incidence.