RecruitingNot ApplicableNCT03172715
Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
Sponsor
Central Finland Hospital District
Enrollment
98 participants
Start Date
Jan 9, 2018
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 65 Years
Inclusion Criteria4
- 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 Criteria17
- 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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Interventions
PROCEDURELocking plate
Osteosynthesis
PROCEDURETKR
Total knee arthroplasty
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT03172715
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