Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures (POSITIF)
Tibial Fractures
About this trial
This is an interventional treatment trial for Tibial Fractures focused on measuring Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial
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
Sites / Locations
- Central Finland HospitalRecruiting
- Kuopio University Hospital
- Päijät-Häme Central Hospital
- Oulu University Hospital
- Seinäjoki Central Hospital
- Coxa Joint Replacement Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ORIF (open reduction-internal fixation)
TKR (total knee replacement)
Osteosynthesis with locking plate(s) will be performed using medial and/or lateral incision, according to morphology of the fracture. Additional osteosynthesis material will be used when necessary. The articular surface will be reduced and bone transplantation or bone substitute used if required. Postoperatively, touch-down weight bearing will be allowed for 6 weeks, followed by 2 weeks of half-weight-bearing period. A walker or wheelchair will be used when necessary.
Arthroplasty of the knee will be performed within two weeks after the fracture. Medial parapatellar approach will be used. The minimal possible constraint of the prosthesis (cruciate retaining, posterior cruciate sacrificing or semi-constrained) will be used. A possible insufficient bone stock may be rebuilt with augments. Hinged prosthesis will be used only if stability of the medial collateral ligament is insufficient. A cemented or uncemented tibial stem extender (minimum length 50mm) will be used in all cases. Additional osteosynthesis will be used when necessary. Postoperatively, the patients will be allowed full weight bearing as tolerated.