Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
- Conditions
- Tibial Fractures
- Interventions
- Procedure: Locking plateProcedure: TKR
- Registration Number
- NCT03172715
- Lead Sponsor
- Central Finland Hospital District
- Brief 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.
- Detailed Description
Intra-articular proximal tibial fractures are relatively common in the elderly. They constitute 8% of all fractures in patients over 65 years. Open reduction and internal fixation (ORIF) is the golden standard treatment for these fractures.
The treatment with ORIF is associated with significant co-morbidity due to complicating concomitant factors, such as osteoporosis, poor co-operation, infection and inadequate stability of osteosynthesis. A high failure rate (30-79 %) of fixation of tibia plateau fractures in elderly people has been reported. Most of these fractures occur in elderly persons who are at risk to lose their ability to walk independently, because of partial immobilization is required initially and full weight bearing is not allowed during 6 to 8 weeks after the operation. The risk of post-traumatic osteoarthritis has been reported to be 5.3-times higher than in the normal population even if adequate stability is achieved and other conditions normalized for fracture healing. It has also been reported that total knee replacement (TKR) performed for post-traumatic arthritis after tibial plateau fracture lead to worse outcome compared with TKR due to primary osteoarthritis. In addition, previous operations increase the risk of complications after TKR. The complication rate in secondary TKR has been reported to be over 18 %.
The available data regarding TKR as a primary treatment option for proximal tibial plateau fracture suggest that fast mobilization and return to normal daily activities may be achieved. These data also suggest a low rate of complications. There are no randomized controlled trials comparing the outcomes of the traditional treatment option (open reduction- internal fixation, ORIF) and TKR as primary treatment of these fractures. In this study investigators compare the outcomes of locking plate osteosynthesis and total knee arthroplasty according to Oxford knee score, pain, ability to walk, or quality of life one year after randomization in 98 patients aged over 65 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ORIF (open reduction-internal fixation) Locking plate 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. TKR (total knee replacement) TKR 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.
- Primary Outcome Measures
Name Time Method Knee function 12 months Oxford knee score 12 months after randomisation
- Secondary Outcome Measures
Name Time Method Reoperations Up to 10 years following randomisation Need for revision surgery
Change in quality of life Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years Short form-36 (SF-36)
Change in knee function Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years Change in Oxford knee score
Satisfaction Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years Satisfaction with knee (Numeric rating scale, range 0 to 10)
Change in physical performance 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years Short Physical Performance Battery (SPPB)
Change in pain Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years Numeric rating scale (rest, night, exercise)
Trial Locations
- Locations (8)
Päijät-Häme Central Hospital
🇫🇮Lahti, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Coxa Joint Replacement Hospital
🇫🇮Tampere, Finland
Turku University Hospital
🇫🇮Turku, Finland
Central Finland Hospital
🇫🇮Jyväskylä, Finland
Seinäjoki Central Hospital
🇫🇮Seinäjoki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland