Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Launched by CENTRAL FINLAND HOSPITAL DISTRICT · May 30, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat a specific type of knee fracture called an intra-articular proximal tibia fracture in patients over 65 years old. The researchers want to find out how well these two treatments work in terms of knee function and pain one year after the injury. The two treatment options being compared are osteosynthesis, which involves using a locking plate to stabilize the fracture, and primary total knee replacement (TKR), where the damaged joint is entirely replaced with an artificial one.

To participate in this study, patients need to have a specific type of fracture and must be willing to consider both treatment options. Some key factors that may make someone eligible include having a fracture that affects the joint with a certain level of severity, having an intact patellar tendon (the tendon connecting the kneecap to the shinbone), and being able to cooperate during the study. However, individuals with severe osteoarthritis, multiple fractures, or other serious health issues may not qualify. If you decide to join the trial, you can expect to be monitored and assessed for knee function and pain over the course of a year, helping researchers determine which treatment might be better for older patients with this type of injury.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Acute intra-articular proximal tibia fracture with impression of the joint cartilage (Schatzker grades II to VI)
• • Impression of tibial plateau min 2 mm
• • Intact patellar tendon
• • The patient accepts both treatment options (osteosynthesis and arthroplasty)
• Exclusion Criteria:
• • Not voluntary
• • Previous arthroplasty of the knee
• • Previous fracture affecting the knee joint
• • Inability to co-operate
• • Not independent (institutionalized living before fracture)
• • Severe osteoarthritis (Kellgren-Lawrence grade 4)
• • Open fracture (Gustilo grade 2 or over)
• • Progressive metastatic malign disease
• • Multiple fractures requiring operative treatment
• • Severe soft tissue injury around the knee (Tscherne classification grade 3)
• • Avulsion fracture of the patellar tendon or concomitant patellar tendon tear
• • Inability to walk before fracture
• • Severe medical comorbidities
• • Body Mass Index over 40
• • Unacceptably high risk of surgery due to severe medical comorbidities
• • Significant arterial or nerve trauma
• • Severe substance abuse