Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 9
- 主要终点
- Knee function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Knee function
时间窗: 12 months
Oxford knee score 12 months after randomisation
次要结局
- 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)
研究者
Juha Paloneva
Department head, adjunct professor
Central Finland Hospital District