Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled Trial

What this Trial Is About

Researchers are comparing two treatments for intra-articular proximal tibia fractures in patients aged 65 and older. The study evaluates knee function and pain one year after treatment using either locking plate osteosynthesis (ORIF) or primary total knee replacement (TKR). These fractures are common in the elderly and often come with complications like osteoporosis and risk of losing independent walking ability. The study addresses the need to compare traditional ORIF treatment with TKR as a primary option, as no randomized controlled trials have done so before. The study involves two treatment groups. One group receives osteosynthesis with locking plates through incisions based on the fracture's shape, with possible use of bone transplantation and additional fixation. Post-surgery, patients follow a weight-bearing schedule starting with limited weight for six weeks. The other group undergoes total knee replacement within two weeks of fracture, using a medial parapatellar approach with prosthesis tailored for stability and bone condition. Patients in this group are allowed full weight bearing as tolerated after surgery. Participants undergo assessments at multiple points up to 10 years, including knee function, pain, physical performance, quality of life, satisfaction, and any reoperations. The main outcome measure is knee function at 12 months. Researchers will use these evaluations to compare the effects of both treatments. The study lasts for many years with follow-ups to monitor long-term results and safety.

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures