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Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

RecruitingNAAges 65 Years - anyAllCentral Finland Hospital District
NCT03172715 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Locking plate
  • TKR
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Where

8 sites
Central Finland Hospital
Jyväskylä, Finland
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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