FRAME Study: Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Ankle Fractures in Frail Older Adults - A Two-Part Multi-Center Randomized Clinical Trial

What this Trial Is About

Researchers are conducting a multi-center randomized controlled trial to compare treatment options for elderly patients with complex or unstable ankle fractures. The study aims to evaluate primary ankle fusion versus open reduction and internal fixation (ORIF) in frail older adults, especially those with significant co-morbidities or compromised soft tissue. The trial explores whether primary ankle fusion or retrograde intramedullary fibular nailing can improve outcomes like pain, function, and complication rates compared to ORIF. Participants will be assigned to one of two parts of the trial based on the fracture complexity. In part 1, patients with severe fractures will receive either a retrograde tibio-talar-calcaneal hindfoot nail for primary ankle fusion or ORIF using modern fixation techniques. In part 2, patients with less complex but unstable fractures will be assigned to receive either retrograde intramedullary fibular nailing (IMFN) or ORIF. The procedures involve specialized surgical techniques tailored to each group. Participants will be followed for at least one year after surgery, with assessments including questionnaires on quality of life, pain, and function, as well as physical tests and complication tracking. Data will be collected during clinic visits and through phone or email contact. Some participants may be contacted at five years for long-term outcome evaluation. The primary outcome measure is the Short-Form 12 health survey at one year post-surgery.

FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)