Clinical efficacy and safety of ultrasound-guided injection with low-molecular-weight peptides from hydrolyzed collagen in patients with first carpometacarpal joint osteoarthritis.

Background: First carpometacarpal (CMC-1) joint osteoarthritis (OA) is a common and disabling condition associated with pain, reduced pinch strength, impaired hand function, and progressive limitations in activities of daily living. Although conservative treatment remains the first therapeutic step, the optimal injectable option for patients with persistent symptoms is still debated. Objective: To evaluate the clinical efficacy and safety of ultrasound (US)-guided intra-articular injection with low-molecular-weight peptides (LWPs) derived from hydrolyzed collagen in patients with symptomatic CMC-1 OA. Methods: This protocol describes a prospective single-arm interventional study enrolling patients with symptomatic and radiographically confirmed CMC-1 OA. All eligible participants will undergo US-guided intra-articular injection with LWPs. The primary endpoint will be the change in pain during activity after 3 months. Secondary outcomes will include pain at rest, hand disability, grip and key pinch strength, rescue analgesic consumption, patient-reported improvement, ultrasonographic findings, treatment-related adverse events, and pain during activity and at rest after 1, 3 and 6 months. Expected results: The study is designed to assess whether the investigational treatment is associated with reduction in pain, improvement in hand function, and an acceptable safety profile over a follow-up period of up to 6 months. A secondary exploratory aim is to identify baseline clinical and US patterns potentially associated with clinical and imaging response. Conclusions: If supported by the study findings, US-guided intra-articular administration of LWPs may represent a promising minimally invasive therapeutic option for patients with CMC-1 OA who remain symptomatic despite standard conservative care.