Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tibial Fractures
- Sponsor
- Central Finland Hospital District
- Enrollment
- 98
- Locations
- 8
- Primary Endpoint
- Knee function
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Juha Paloneva
Department head, adjunct professor
Central Finland Hospital District
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)
Outcomes
Primary Outcomes
Knee function
Time Frame: 12 months
Oxford knee score 12 months after randomisation
Secondary Outcomes
- Reoperations(Up to 10 years following randomisation)
- Change in quality of life(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years)
- Change in knee function(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years)
- Satisfaction(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years)
- Change in physical performance(6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years)
- Change in pain(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years)