RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability

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RHEVOLUTION Clinical Trial: Radial Head Arthroplasty for the Treatment of Acute Traumatic Elbow Instability, a Randomized Trial Comparing Two Implant Desings Principal Investigator/collaborators: Dr. Raúl Barco, Dr. Blanca Diez Sánchez, Dr. Juan Ameztoy Gallego, Dr. Luis Palacios, Dr. Alfonso Vaquero-Picado and Dr. Samuel Antuña, Department: Orthopedic Surgery and Traumatology Institution: La Paz University Hospital Introduction: Participants are being invited to participate in a clinical research study. Our intention is to provide participants with clear and sufficient information so that participants may decide whether or not wish to participate. The investigators will answer any questions participants may have at any time. Participants may also discuss this information with anyone participants consider appropriate before making the decision. Voluntary Participation: Participants' participation in this study is entirely voluntary. Participants may decide not to participate or withdraw the consent at any time without providing any explanation. Participants' decision will not affect the relationship with the doctor nor the medical care it is received in any way. Study Description and Objectives: Participants are being invited to participate in a clinical study that aims to compare the outcomes of two elbow arthroplasties commonly used at our center to replace a portion of the elbow fractured by a fall that cannot be fixed. The fracture affects the radial head, and when fixation is not viable, the radial head is replaced with an arthroplasty. Many different radial head arthroplasties have been designed to replace the bone, and overall, they have enabled patients with complex elbow fractures to regain mobility, stability, and return to sports activities at a level similar to before the fracture. However, some patients experience stiffness, nerve irritation, clicking sounds, or episodes of instability that they consider limiting in their lives. In these cases, it is sometimes necessary to remove the prosthesis if the symptoms are limiting. Currently, although all prosthesis models have demonstrated good performance and achieve good results, the investigators do not know which design is best for each patient and type of fracture. The purpose of this study is to compare two types of radial head arthroplasties commonly used in La Paz Hospital for these fractures, to determine if they achieve similar clinical outcomes after 24 months of follow-up. The investigators want to analyze whether there are differences in satisfaction, range of motion, and functionality in patients operated on with one design or the other, with a stable elbow in both groups. This is a randomized clinical trial, meaning that participants will be assigned to one of the two designs by chance (similar to flipping a coin). The operation will be the same for everyone, only the design of the arthroplasty used will change. One group of patients will receive an anatomic design (Align model from Skeletal Dynamics) and the other group will receive a spacer design (Evolve model from Stryker). Both procedures are performed by experienced surgeons and are safe. Follow-up will include clinical and radiological examinations for at least 24 months after surgery. The clinical follow-up and treatment will be the same whether participants decide to get involved in the study or not, as all procedures correspond to standard clinical practice. Participants' medical care will not depend on participation in this study. If participants decide to participate, it is necessary to sign an Informed Consent form. This study will be conducted at La Paz University Hospital and aims to include approximately 90 patients. The study has been approved by the Research Ethics Committee in La Paz University Hospital in accordance with European Regulation 2017/745 and National Royal Decree 192/2023, which regulates medical devices. Participants may not directly benefit from participating in this study. However, the results may contribute to improved knowledge regarding radial head fractures and arthroplasty in patients who had a complex elbow fracture. Financial Compensation: The participation will not result in any additional cost to participants. No financial compensation will be provided. Contact Information: If participants have any questions regarding the study, the use of medical data, or if participants have concerns or complaints related to the study, the contact will be: Dr. Blanca Diez Sánchez, Dr. Juan Ameztoy Gallego or Dr. Raul Barco Laakso Telephone: +34 91 727 70 00 Ext. 47425

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