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

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