Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Recruiting now · Not applicable

Conditions studied: Tibial Fractures

In brief

The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.

Key facts

Study ID

NCT03172715

Run by

Central Finland Hospital District

People needed

98

Starts

2018-01-09

Expected to finish

2029-06-01

Last updated by the study team

2024-08-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Central Finland Hospital — Jyväskylä, Finland (enrolling)
• Kuopio University Hospital — Kuopio, Finland
• Päijät-Häme Central Hospital — Lahti, Finland
• Oulu University Hospital — Oulu, Finland
• Seinäjoki Central Hospital — Seinäjoki, Finland
• Coxa Joint Replacement Hospital — Tampere, Finland
• Tampere University Hospital — Tampere, Finland
• Turku University Hospital — Turku, Finland

Full record on ClinicalTrials.gov

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