To Study the effect of early versus late weight bearing after osteosynthesis of proximal tibia fractures.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. To identify difference in gait patterns among patients with early weight bearing protocol and late weight bearing protocol by measuring lower limb symmetry indices after osteosynthesis of proximal tibia fractures.
研究概览
简要总结
BRIEF SUMMARY-
Tibia plateau fractures (TPFs) are result commonly from motor vehicle accidents or fall from height .The incidence of patients with tibia plateau fractures is approximately 13.3 per 100,000 and it represents approximately 1.2% of all fractures in adults, most commonly seen in the age group of 40-60 in both the sexes.
Among lower limb fractures, Tibia plateau fractures account for 2% of
lower limb fractures with incidence ranging from 116/100,000 to 427/100,000.
Tibia plateau fracture is a high velocity injury and often associated with high risk of
complications; because of extensive soft-tissue damage swelling, compartment syndrome,
neurovascular injuries, surgical site infection and deep vein thrombosis. Secondary complications in
long term outcome are not rare to see, manifesting as knee instability or stiffness, angular
deformities, mal-union and post-traumatic osteoarthritis.
. Apart from surgical hurdles and challenges, tibia plateau fractures have significant negative impact on daily activities of patients and
their economic prosperity. They are associated with disruption of physical and functional integrity of
knee joint and the mental menace of being in pain and confined to bed.
Since emergence of advanced imaging, implants and surgical principles and approaches, the
functional outcome has improved long way. But the post operative recovery after such fracture
rehabilitation after osteosynthesis is a long, tedious task for patient which involves refraining from
weight- bearing for long-duration as advocated by AO guideline.
. The fear of early weight bearing is associated with loss of the reduction, however the same is obviated by recent research such as that of Williamson et al.
Our concern about the early weight bearing protocol is that it may lead to subjective
improvement in the gait without any objective improvement in the gait parameter and on the
contrary aggressive protocol may adversely affect the cartilage response at stage of healing. Same
we wish to prove and disprove with our proposed study/research protocol.
NULL HYPOTHESIS:
There is no difference between Early-weight bearing protocol and Non-weight bearing
protocol on the outcome after osteosynthesis of proximal tibia fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Closed Intra-articular proximal tibia fractures in skeletally mature patients, requiring osteosynthesis.
排除标准
- •Intra-articular fracture not requiring osteosynthesis,
- •Intra-articular eminence fracture,
- •Open fractures,
- •Associated other lower limb fracture,
- •Foot deformities,
- •Limb length discrepancy >2cm,
- •Pathological fracture,
- •Skeletally immature patient, 9 Neurological injury,
- •Vascular injury,
- •Late presentation after >3weeks,
- •Previous surgery of the knee,
- •Previous septic episode,
- •Post-traumatic deformity,
- •Inflammatory arthritis,
- •Pre-existing degenerative Osteoarthritis,
- •Neuromuscular disorder involving either of lower limb.
结局指标
主要结局
1. To identify difference in gait patterns among patients with early weight bearing protocol and late weight bearing protocol by measuring lower limb symmetry indices after osteosynthesis of proximal tibia fractures.
时间窗: Lower limb symmetry indices and synovial fluid biomarkers to be assessed at 6 months postoperatively.
2. To study the effect of early weight bearing protocol and late weight bearing protocol in patients after osteosynthesis of proximal tibia fracture on synovial fluid biomarkers.
时间窗: Lower limb symmetry indices and synovial fluid biomarkers to be assessed at 6 months postoperatively.
次要结局
- To study the difference between early and late weight bearing protocol after osteosynthesis of proximal tibia fractures on(functional and radiological outcome.)